A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change of ulcer surface area
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard-of-care managed group
This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers
干预措施: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers (Other)
S26E
This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers plus daily S26E application
干预措施: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers (Other)
S26E
This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers plus daily S26E application
干预措施: S26E (Drug)
结局指标
主要结局
Change of ulcer surface area
时间窗: 12 weeks after enrollment in the study
% change of ulcer surface area
次要结局
- Incidence of adverse events(12 weeks after enrollment in the study)
- Percentage of completely healed ulcers(12 weeks after enrollment in the study)
- Incidence of amputations(12 weeks after enrollment in the study)
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens