Application of S26E for Diabetic Foot Ulcer Healing

NCT ID: NCT04186377

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-11-29

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard-of-care managed group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing

S26E

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing

S26E

Intervention Type: DRUG

Daily application of S26E extract on wound site

Interventions

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

Intervention Type: OTHER

S26E

Daily application of S26E extract on wound site

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Alexandros Kokkinos

Associate Professor in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, , Greece

Countries

Greece

References

Cheikhyoussef N, Kandawa-Schulz M, Bock 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.

Reference Type: BACKGROUND

PMID: 28868224 (View on PubMed)

Silva JR, Burger B, Kuhl 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.

Reference Type: BACKGROUND

PMID: 29849484 (View on PubMed)

Other Identifiers

S26E for neuropathic ulcers

Identifier Type: -

Identifier Source: org_study_id