Phase 3
N=68
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Diabetic Foot Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02789033 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Biopsies — 2.46; 2.64; 2.56; 2.07 UI/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chitosan (Drug); Isosorbide dinitrate (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biopsies |
2.46; 2.64; 2.56; 2.07; 2.38; 2.28 | — |
Summary
The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition is more frequent in elder patients. It is estimated that about 5% of all patients with diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while 10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb amputation could also be involved in a new amputation in the next year; higher or in the other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading device, wound care and surgery in selected cases. However, treatment of DFU remains challenging because of unsatisfactory results from surgical and non-surgical treatments. Many adjunctive therapies are designed to improve the care of DFU including negative pressure wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB) Hyperbaric oxygen and acellular matrix product among others.
Eligibility Criteria
Inclusion Criteria
- Patients with diabetic foot ulcers in grade I and II of the classification of Wagner
- with leg arm index> 0.8 and
- without specific treatment for foot ulcers referred to the experimental and clinical
Exclusion Criteria
- Patients with another type of topical medication
- patients with diabetic foot ulcers in grade III and
- with leg arm index <0.8
Data sourced from ClinicalTrials.gov (NCT02789033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.