CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
NorLeu3-A(1-7) in a gel formulationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00796744
NCT00796744Phase 2Completed

Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers

US Biotest, Inc.·interventional·Posted Nov 24, 2008·Updated Sep 27, 2012

In Brief

A Phase 2 clinical trial evaluating NorLeu3-A(1-7) in a gel formulation for Foot Ulcer, Diabetic and Diabetic Foot. Completed, enrolled 78 participants across 12 sites.

Detailed Summary

The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2010
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago

Interventions

NorLeu3-A(1-7) in a gel formulationdrug

Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.