Trial Outcomes & Findings for The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study (NCT NCT01217476)
NCT ID: NCT01217476
Last Updated: 2014-08-05
Results Overview
wound closure is defined as 100% reepithelialization of the target DFU, without exudates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-08-05
Participant Flow
Participant milestones
| Measure |
Trafermin
Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
|
Placebo
Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
102
|
|
Overall Study
COMPLETED
|
93
|
95
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Trafermin
Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
|
Placebo
Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is \>6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Surgery on the Target Limb
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study
Baseline characteristics by cohort
| Measure |
Trafermin
n=105 Participants
Trafermin 0.01% spray
|
Placebo
n=102 Participants
Matching placebo spray
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
59.4 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Wound size ≤5cm^2
|
81 participants
n=99 Participants
|
80 participants
n=107 Participants
|
161 participants
n=206 Participants
|
|
Wound size >5cm^2
|
24 participants
n=99 Participants
|
22 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Peripheral blood perfusion Impaired
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Peripheral blood perfusion Normal
|
88 participants
n=99 Participants
|
86 participants
n=107 Participants
|
174 participants
n=206 Participants
|
|
BMI
|
30.19 kg/m2
STANDARD_DEVIATION 5.15 • n=99 Participants
|
30.31 kg/m2
STANDARD_DEVIATION 4.92 • n=107 Participants
|
30.25 kg/m2
STANDARD_DEVIATION 5.02 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The primary analysis of the efficacy criteria was conducted on the ITT population.
wound closure is defined as 100% reepithelialization of the target DFU, without exudates.
Outcome measures
| Measure |
Trafermin
n=105 Participants
Trafermin 0.01% spray
|
Placebo
n=102 Participants
Matching placebo spray
|
|---|---|---|
|
Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares
|
21.0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The analysis of the efficacy criteria was conducted on the ITT population.
The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.
Outcome measures
| Measure |
Trafermin
n=105 Participants
Trafermin 0.01% spray
|
Placebo
n=102 Participants
Matching placebo spray
|
|---|---|---|
|
Relative Wound Area Regression of 40% or More at 6 Week
|
53.3 percentage of participants
|
55.9 percentage of participants
|
Adverse Events
Trafermin
Serious events: 20 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 26 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trafermin
n=105 participants at risk
Trafermin 0.01% spray
|
Placebo
n=102 participants at risk
Matching placebo spray
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
General disorders
Sudden death
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Diabetic foot infection
|
3.8%
4/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
7.8%
8/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Erysipelas
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Liver abscess
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
3.9%
4/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Sepsis
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Investigations
Glycosylated hemoglobin increased
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
2.9%
3/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
2.0%
2/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Metabolism and nutrition disorders
Neuroglycopenia
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Nervous system disorders
Transient ischemic attack
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.95%
1/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.00%
0/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
0.98%
1/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
Other adverse events
| Measure |
Trafermin
n=105 participants at risk
Trafermin 0.01% spray
|
Placebo
n=102 participants at risk
Matching placebo spray
|
|---|---|---|
|
General disorders
Edema peripheral
|
6.7%
7/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
10.8%
11/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Infections and infestations
Diabetic foot infection
|
8.6%
9/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
11.8%
12/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
22.9%
24/105 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
16.7%
17/102 • Primary Treatment Emergent Adverse Event: adverse events that occurred after starting the treatment with the study medication until the end of primary follow up period up to 24 weeks.
The safety population included all patients who were randomized and exposed to the study treatment.
|
Additional Information
Mr. Akira Kondo, Manager, Clinical R&D
Olympus France S.A.S
Phone: +33-1-4560-6849
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI have no implicit or explicit rights to publish study data and results of their services.
- Publication restrictions are in place
Restriction type: OTHER