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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

• Chronic foot ulcer (> 1month) (at or below the ankle) grade 1A, 2A (University of Texas Wound Classification System) with an ulcer area between 150-350 mm2.

• No ulcer should present a moderate or severe infection at baseline. Concomitant treatment with systemic antibiotics at baseline is accepted if all ulcers meet none of the criteria defining moderate or severe infection.

• Toe/brachial index >0.6 and/or Tcp02 >50mmHg or ankle/brachial index >0.65, or the pulses at dorsalis pedis/tibialis posterioris clearly palpable.

• If more than one ulcer is present, the largest ulcers that fulfill inclusion criteria will be included

• Patient should be compliant to one of the accepted off-loading system.

• Patients will be able to provide written informed consent

Exclusion Criteria:

• Acute cardiovascular event (myocardial infarction/unstable angina, stroke) within three months prior to randomisation

• Subjects who have undergone vascular reconstruction or angioplasty less than 3 months prior to randomisation

• Decompensated congestive heart failure or functional class 3-4.

• Childbearing potential

• Impaired hepatic function (2 times upper normal limit of ASAT and ALAT)

• Severe renal failure (GFR calculated after Cockcroft's formula <30 ml/min/1.73 m2)

• Ongoing treatment with immunosuppressive drugs

• HbA1c >12 % (108 mmol/l)(12%)

• Polyglobulia (EVF>0.60 men, EVF> 0.56 women)

• Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol

• Malignancy other than basal-cell carcinoma and cervical carcinoma in situ, requiring any general, local, surgical or radiation therapy.

• History of alcohol or drug abuse

• Osteomyelitis defined as:

1. There is a clinical suspicion of osteomyelitis;

2. Ulcer considered for treatment is located at the site of a past amputation;

3. History of acute osteomyelitis in the past 90 days or history of recurrent osteomyelitis; or

4. A positive "probe to bone" test.

• Participant in another ongoing study

• Known hypersensitivity to deferoxamine

• Unwillingness to participate following oral and written information

• Subjects with any other severe acute or chronic medical or psychiatric condition that make the subject inappropriate for the study in the judgment of the investigator.