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Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes Institute.

NCT03239457 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-08-04

No results posted yet for this study

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.

Conditions

  • Diabetic Foot

Interventions

BIOLOGICAL

Heberprot P

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.

Sponsors & Collaborators

  • Cuban Center for Genetic Engineering and Biotechnology

    collaborator OTHER

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Rafael Ibargollín Ulloa, MD, MSc · Cuban Center for Genetic Engineering and Biotechnology

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239457 on ClinicalTrials.gov