Application of S26E for Diabetic Foot Ulcer Healing

• Status: Recruiting
• Trial end date: 2021-11-29
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.

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

Details

• Lead Sponsor: National and Kapodistrian University of Athens

Criteria

Inclusion Criteria:

• Type 1 or type 2 Diabetes Mellitus

• Body Mass Index <40 kg/m2

• Glycated Hemoglobin (HbA1c) <10%

• Presence of a diabetic foot ulcer with the following features i) Owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an Ankle-Brachial index <0.4 ) ii) Persistence for >12 weeks iii) Already following an adequate off-loading method

Exclusion Criteria:

• Presence of clinical signs of infection

• Inability or refusal to follow off-loading methods

• Ulcer surface area decline by >15% during the run-in period

• Malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded)

• Acute Charcot arthropathy

• Serious chronic Hepatic (Child-Pugh B or C), Renal (stage 4-5 CKD) or Heart (NYHA 3-4) disease

• Known hypersensitivity to the product or its contents

• Any random glucose measurement >350 mg/dl during the run-in period