Application of S26E for Diabetic Foot Ulcer Healing

2019-12-09 00:55:46 | BioPortfolio


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.


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 Design


Diabetic Foot


Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers, S26E


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




National and Kapodistrian University of Athens

Results (where available)

View Results


Published on BioPortfolio: 2019-12-09T00:55:46-0500

Clinical Trials [3166 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the safety of t...

Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. Patients participating in the study may receive an activ...

BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. The objective of this study is to evaluate the...

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in patients with neuropathic diabetic foot ulcers that do not respon...

Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.

PubMed Articles [16386 Associated PubMed Articles listed on BioPortfolio]

Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials.

The objective of this paper is to present the secondary safety and efficacy outcomes from two studies of focused extracorporeal shockwave therapy (ESWT) used adjunctively with standard care in the tre...

Why and how to off-load a diabetic foot ulcer ?

The off-loading of diabetic foot ulcers is the most urgent and theoretically the easiest treatment to implement. Its effectiveness has been proven for decades by randomized controlled studies on neuro...

Swift Downregulation of Gelatinases (MMP-2, MMP-9) in Neuropathic Diabetic Foot Ulcers Treated With Total Contact Cast.

The aim of this study is to evaluate how treatment with total contact cast (TCC) affects the balance of proteases in diabetic foot ulcers (DFUs) as they heal.

Implementation of NICE technology guidance on venous leg ulcers and diabetic foot ulcers: a conference report.

Implementation of evidence-based care is central to achieving good results. In the UK, this involves implementing guidance from the National Institute for Health and Care Excellence (NICE). Here, , c...

Methodological approaches for assessing the cost of diabetic foot ulcers: a systematic literature review.

To evaluate the methodological approaches used to assess the cost consequences of diabetic foot ulcers (DFUs) in published scientific papers.

Medical and Biotech [MESH] Definitions

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Devices used to support or align the foot structure, or to prevent or correct foot deformities.

Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.

More From BioPortfolio on "Application of S26E for Diabetic Foot Ulcer Healing"

Quick Search

Relevant Topics

Complementary and Alternative Medicine
Alternative medicine are whole medical systems that did not fit with conventional medicine as they have completely different philosophies and ideas on the causes of disease, methods of diagnosis and approaches to treatment. Although often overlapping, co...

Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

Searches Linking to this Trial