Application of S26E for Diabetic Foot Ulcer Healing (NCT04186377) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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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
What they're measuring
1
Change of ulcer surface area
Timeframe: 12 weeks after enrollment in the study
Trial details
NCT IDNCT04186377
SponsorNational and Kapodistrian University of Athens