CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Heberprot Pbiological
Likely dose
Heberprot P 75 µgfrom 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/NCT03239457
NCT03239457N/ACompleted
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Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes Institute. Demonstrative Study

Dasman Diabetes Institute·observational·Posted Aug 4, 2017·Updated Aug 4, 2017

In Brief

An observational study evaluating Heberprot P for Diabetic Foot. Completed, enrolled 50 participants.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot
Countries--
CollaboratorsCuban Center for Genetic Engineering and Biotechnology

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartDec 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

Heberprot Pbiological

75 µg vials administered at the rate of a vial 3 times per week (Sunday Tuesday, Thursday) by intralesional and perilesional route.For this, the reconstitution and dilution of the vial will be carried out with 5 mL of water for injection. The administrations will be kept up to 8 weeks of treatment or until there is achieved granulation of the 100 % of the lesion.