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.

NCT04186377

Conditions

1. Diabetic Foot
2. Neuropathic Foot Ulcer
3. Chronic Diabetic Ulcer of Left Foot (Diagnosis)
4. Chronic Diabetic Foot Ulcer of Right Foot

Interventions

1. Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers
2. Drug: S26E

MeSH:Diabetic Foot Foot Ulcer Ulcer

A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing. --- S26E ---

Application of S26E for Diabetic Foot Ulcer Healing 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. --- S26E ---

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 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 Diabetic Foot Neuropathic Foot Ulcer Chronic Diabetic Ulcer of Left Foot (Diagnosis) Chronic Diabetic Foot Ulcer of Right Foot Diabetic Foot Foot Ulcer Ulcer This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (>12 weeks) diabetic foot ulcers. --- S26E ---

The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. --- S26E ---

The safety of topical S26E application on human skin has been clinically demonstrated. --- S26E ---

Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). --- S26E ---

After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). --- S26E ---