Application of S26E for Diabetic Foot Ulcer Healing

Phase 2

Terminated

• Conditions: Chronic Diabetic Ulcer of Left Foot (Diagnosis); Neuropathic Foot Ulcer; Diabetic Foot; Chronic Diabetic Foot Ulcer of Right Foot
• Interventions: Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers; Drug: S26E

• Registration Number: NCT04186377
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Detailed 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)

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Study Start: 2020-05-15
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of ulcer surface area	12 weeks after enrollment in the study	% change of ulcer surface area

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	12 weeks after enrollment in the study	Incidence of product-related adverse events (local or systemic infection, local hypersensitivity reactions)
Percentage of completely healed ulcers	12 weeks after enrollment in the study	Percentage of participants to achieve ulcer healing within the observation period
Incidence of amputations	12 weeks after enrollment in the study	Number of patients that required an amputation

Trial Locations

Locations (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine; 🇬🇷 Athens, Greece