Application of S26E for Diabetic Foot Ulcer Healing

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04186377
• Other study ID #: S26E for neuropathic ulcers
• Status: Terminated
• Phase: Phase 2
• Start date: May 15, 2020
• Est. completion date: November 29, 2021

Study information

• Verified date: June 2022
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcer of Right Foot
• Chronic Diabetic Ulcer of Left Foot (Diagnosis)
• Diabetic Foot
• Foot Ulcer
• Neuropathic Foot Ulcer
• Ulcer

Intervention

Other:
• Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers
Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing

Drug:
• S26E
Daily application of S26E extract on wound site

Locations

Country	Name	City	State
Greece	Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Cheikhyoussef N, Kandawa-Schulz M, Böck R, de Koning C, Cheikhyoussef A, Hussein AA. Characterization of Acanthosicyos horridus and Citrullus lanatus seed oils: two melon seed oils from Namibia used in food and cosmetics applications. 3 Biotech. 2017 Oct;7(5):297. doi: 10.1007/s13205-017-0922-3. Epub 2017 Aug 31. — View Citation

Silva JR, Burger B, Kühl CMC, Candreva T, Dos Anjos MBP, Rodrigues HG. Wound Healing and Omega-6 Fatty Acids: From Inflammation to Repair. Mediators Inflamm. 2018 Apr 12;2018:2503950. doi: 10.1155/2018/2503950. eCollection 2018. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ulcer surface area	% change of ulcer surface area	12 weeks after enrollment in the study
Secondary	Percentage of completely healed ulcers	Percentage of participants to achieve ulcer healing within the observation period	12 weeks after enrollment in the study
Secondary	Incidence of adverse events	Incidence of product-related adverse events (local or systemic infection, local hypersensitivity reactions)	12 weeks after enrollment in the study
Secondary	Incidence of amputations	Number of patients that required an amputation	12 weeks after enrollment in the study