TerminatedPhase 2

Application of S26E for Diabetic Foot Ulcer Healing

Stopped: Inability to recruit subjects

Greece5 participantsStarted 2020-05-15

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of ulcer surface area

Timeframe: 12 weeks after enrollment in the study

Trial details

NCT IDNCT04186377

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-29

View on ClinicalTrials.gov More Diabetic Foot trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.