Trial Outcomes & Findings for Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers (NCT NCT04046120)
NCT ID: NCT04046120
Last Updated: 2026-03-19
Results Overview
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : * experimental group: uncovered heel * control group: heel covered by the bandage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)
Results posted on
2026-03-19
Participant Flow
24 months of recruiting in hospital Each participant was followed between 4 to 6 weeks Recruitment began on the first inclusion : 10/11/2019 and the research ended with the last visite of the last patient on 06/03/2022. This study was designed as a monocentric, prospective, controlled, randomized in parallel groups, non-inferiority clinical trial.
Eligible according to the inclusion and non-inclusion criteria
Participant milestones
| Measure |
Heel Included
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Heel Included
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Overall Study
Wounds healed before the end of follow-up
|
3
|
2
|
|
Overall Study
Patient hospitalized
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Change of arm after randomization
|
1
|
1
|
|
Overall Study
Refusal by the nursing home to carry out the protocol:
|
0
|
1
|
|
Overall Study
Discontinuation of the study due to inability to tolerate the bandage
|
2
|
1
|
|
Overall Study
Bandage redone between V2 and V3
|
1
|
0
|
|
Overall Study
Postponed visit- COVID
|
1
|
2
|
Baseline Characteristics
The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
Baseline characteristics by cohort
| Measure |
Heel Included
n=51 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=51 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
41 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
44 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
85 Participants
n=102 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 14.4 • n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
77.7 years
STANDARD_DEVIATION 12.8 • n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
76.05 years
STANDARD_DEVIATION 13.6 • n=102 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
|
Sex: Female, Male
Female
|
17 Participants
n=51 Participants
|
32 Participants
n=51 Participants
|
49 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=51 Participants
|
19 Participants
n=51 Participants
|
53 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
51 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
51 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
102 Participants
n=102 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient
|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
0 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
0 Participants
n=102 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
7 Participants
n=51 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
17 Participants
n=102 Participants • The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: * Wounds healed before the end of follow-up: 5 patients * Postponed visit - COVID: 3 patients * Discontinuation of the study due to inability to tolerate the bandage: 3 patients * Change of arm after randomization: 2 patients * Refusal by the nursing home to carry out the protocol: 1 patient * Patient hospitalized: 1 patient * Death: 1 patient * Bandage redone between V2 and V3: 1 patient
|
PRIMARY outcome
Timeframe: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : * experimental group: uncovered heel * control group: heel covered by the bandage.
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Interface Pressure at V3
|
28.4 mmHg
Interval 26.2 to 30.5
|
30.1 mmHg
Interval 28.0 to 32.3
|
SECONDARY outcome
Timeframe: Day 0 and the last day at V3 (between week 4 and week 8)Compare the evolution or appearance of an edema in the ankle. The circumference of the ankle is measured with a tape measure using a technique called the figure of 8.
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Ankle Circumference
|
62.4 cm
Interval 60.9 to 63.9
|
58.9 cm
Interval 57.4 to 60.4
|
SECONDARY outcome
Timeframe: 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks)Compare, between the two groups, the interface pressures measured during the installation of bandage at home by the home nurse (V2 follow-up visit), compared to the recommended pressures (30-40 mmHg)
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Interface Pressure at V2
|
36.4 mmHg
Interval 34.6 to 38.2
|
39.7 mmHg
Interval 37.9 to 41.6
|
SECONDARY outcome
Timeframe: At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks)Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Interface Pressure Between V2 and V3
|
-8 mmHg
Interval -9.8 to -6.2
|
-9.7 mmHg
Interval -11.5 to -7.9
|
SECONDARY outcome
Timeframe: At the last visit of the protocol (Between 4 and 8 weeks)Between the two groups, compare patient satisfaction with a heterogeneous questionnaire. There is no scale or score. It is asked which type of bandage the patient prefers: with or without heel included?
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Patient Satisfaction: Questionnaire
Among the patients who have experienced the two technics "I prefer the heel-wrapped technique"
|
8 Participants
|
6 Participants
|
|
Patient Satisfaction: Questionnaire
Among the patients who have experienced the two technics 'I don't know'
|
2 Participants
|
9 Participants
|
|
Patient Satisfaction: Questionnaire
Among the patients who have experienced the two technics"I prefer the heel-free technic"
|
3 Participants
|
20 Participants
|
|
Patient Satisfaction: Questionnaire
Missing data
|
30 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 0Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure
Outcome measures
| Measure |
Heel Included
n=43 Participants
The bandage is made by including the heel as recommended in routine.
|
Heel Not Included
n=42 Participants
he bandage is made by leaving the heel uncovered.
Heel-free bandage: The bandage is made by leaving the heel uncovered.
|
|---|---|---|
|
Number of Bandage Repairs
one bandage repair
|
37 Participants
|
30 Participants
|
|
Number of Bandage Repairs
2 bandage repair
|
5 Participants
|
12 Participants
|
|
Number of Bandage Repairs
3 bandage repair
|
1 Participants
|
0 Participants
|
Adverse Events
Heel Included
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heel Not Included
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Madam Anne MAUVILAIN-POTTIER
CHU of Nantes - Mobile vascular wound care unit
Phone: 0240083473
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place