Mode
Text Size
Log in / Sign up
Phase 3 N=68 Randomized Double-blind Treatment

Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers

Diabetic Foot Ulcers

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search