Efficacy of Extracorporeal Shockwave Therapy for Management of Diabetic Foot Ulcer at The Townsville Hospital

The Townsville Hospital0 个研究点目标入组 50 人开始时间: 2015年11月9日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Diabetes age >18 years
•2. Stable documented diabetic foot ulcer of full-thickness skin defect requiring >14 days of healing.
•3. Exclusion of other etiologies of foot ulcer.

•1. Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.).
•2. Any major surgery up to 4 weeks prior to the day of enrolment or any planned surgery prior to study completion including any major surgical intervention for the diabetic foot ulcer.
•3. Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g. Lupus erythematodes, scleroderma, etc.), chronic inflammatory diseases (e.g. inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma.
•4. Treatment with normothermic or hyperbaric oxygen therapy.
•5. Skin and dermal substitutes within 30 days prior to study enrolment.
•6. Enzymatic debridement treatment.
•7. Participation in any other clinical trial.
•8. Inability to comply with study protocol.

发起方

The Townsville Hospital