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Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcers

NCT03137966 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-05-26

No results posted yet for this study

Summary

Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and represents a big economic burden for the society. No specific therapy is available for diabetic foot ulcers.The aim of this study is to define a new approach for treatment of chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1 inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The primary objective of the study will be the reduction with \>50% of the wound area after 12 weeks of treatment.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Deferoxamine

Deferoxamine (0.66mg/ml) will be applied locally as a gel (3 times a week) for a period of maximum three months or until intact skin.

DRUG

Placebo

Placebo will be applied locally as a gel (3 times a week) for a period of maximum three months or until intact skin.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Sergiu Catrina, MD/Ass.Prof. · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2025-12-31
Completion
2026-06-30

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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 NCT03137966 on ClinicalTrials.gov