Trial Outcomes & Findings for Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers (NCT NCT02789033)
NCT ID: NCT02789033
Last Updated: 2021-01-12
Results Overview
Histological changes in ulcers
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
75 days
Results posted on
2021-01-12
Participant Flow
ADDITIONAL PARTICIPANTS WERE INCLUDED ANTICIPATING PARTICIPANTS WHO DO NOT COMPLETE THE CLINICAL TRIAL
Participant milestones
| Measure |
Active Comparator: Chitosan
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
And
Placebo in the same pharmacological presentation that Isosorbide dinitrate spray
|
Active Comparator: Isosorbide Dinitrate Spray
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Placebo in the same pharmacological presentation that Chitosan
|
Combination: IDS and Chitosan
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
|
Placebo Comparator: Placebo
Placebo in the same pharmacological presentation that both, IDS and Chitosan.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Active Comparator: Chitosan
n=17 Participants
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
And
Placebo in the same pharmacological presentation that Isosorbide dinitrate spray
|
Active Comparator: Isosorbide Dinitrate Spray
n=17 Participants
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Placebo in the same pharmacological presentation that Chitosan
|
Combination: IDS and Chitosan
n=17 Participants
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
|
Placebo Comparator: Placebo
n=17 Participants
Placebo in the same pharmacological presentation that both, IDS and Chitosan.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
68 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
32 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
36 Participants
n=390 Participants
|
|
Diameter of the ulcer
|
10.5 centimeters
STANDARD_DEVIATION 5.8 • n=99 Participants
|
12.1 centimeters
STANDARD_DEVIATION 7.0 • n=107 Participants
|
11.4 centimeters
STANDARD_DEVIATION 8.2 • n=206 Participants
|
15.8 centimeters
STANDARD_DEVIATION 9.3 • n=157 Participants
|
12.3 centimeters
STANDARD_DEVIATION 7.5 • n=390 Participants
|
PRIMARY outcome
Timeframe: 75 daysHistological changes in ulcers
Outcome measures
| Measure |
Active Comparator: Chitosan
n=15 Participants
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
And
Placebo in the same pharmacological presentation that Isosorbide dinitrate spray
|
Active Comparator: Isosorbide Dinitrate Spray
n=15 Participants
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Placebo in the same pharmacological presentation that Chitosan
|
Combination: IDS and Chitosan
n=16 Participants
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
And
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
|
Placebo Comparator: Placebo
n=15 Participants
Placebo in the same pharmacological presentation that both, IDS and Chitosan.
|
|---|---|---|---|---|
|
Biopsies
desmin
|
2.3 UI/dL
Standard Deviation 0.8
|
2.5 UI/dL
Standard Deviation 0.6
|
2.6 UI/dL
Standard Deviation 0.6
|
2.3 UI/dL
Standard Deviation 0.6
|
|
Biopsies
α-smooth muscle actin
|
2.46 UI/dL
Standard Deviation 0.6
|
2.64 UI/dL
Standard Deviation 0.6
|
2.56 UI/dL
Standard Deviation 0.6
|
2.07 UI/dL
Standard Deviation 0.6
|
|
Biopsies
Von Willebrand Factor
|
2.38 UI/dL
Standard Deviation 0.65
|
2.28 UI/dL
Standard Deviation 0.82
|
2.31 UI/dL
Standard Deviation 0.8
|
2.15 UI/dL
Standard Deviation 0.5
|
|
Biopsies
vascular endothelial growth factor-A
|
2.23 UI/dL
Standard Deviation 0.8
|
2.6 UI/dL
Standard Deviation 0.6
|
2.43 UI/dL
Standard Deviation 0.6
|
2.07 UI/dL
Standard Deviation 0.7
|
Adverse Events
Active Comparator: Chitosan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Isosorbide Dinitrate Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination: IDS and Chitosan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Comparator: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
PhD. Leonel García Benavides
Universidad de Guadalajara
Phone: +52 (33) 20 00 23 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place