Application of S26E for Diabetic Foot Ulcer Healing

National and Kapodistrian University of Athens

Status and phase: Terminated; Phase 2

Conditions: Diabetic Foot; Chronic Diabetic Ulcer of Left Foot (Diagnosis); Chronic Diabetic Foot Ulcer of Right Foot; Neuropathic Foot Ulcer

Treatments: Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers; Drug: S26E

Study type: Interventional

Funder types: Other

Identifiers

NCT04186377

S26E for neuropathic ulcers

Details and patient eligibility

About

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.

Full description

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

Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for >12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. 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). 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). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Standard-of-care managed group

Active Comparator group

Description:

This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers

Treatment:

Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers

S26E

Experimental group

Description:

This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers plus daily S26E application

Treatment:

Drug: S26E

Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers