Patients with a history of DFU whose healing time of foot ulcer was over 3 months will be invited to participate in our trial by phone. Individuals will be eligible for the trial if they meet the following inclusion criteria: (1) aged ≥ 18 years, (2) type 1 diabetes (T1DM) or type 2 diabetes (T2DM), (3) decrease or loss of protective foot sensation due to/as a result of diabetic peripheral neuropathy, and (4) had a healed foot ulceration in the 3 months prior to randomization. However, individuals will not be enrolled into this trial if they meet the following exclusion criteria: (1) amputation proximal to the tarsometatarsal joint, (2) the use of walking aids that offload the foot, (3) severe lower extremity artery disease (ankle brachial index ≤ 0.4, intermittent claudication or rest pain), (4) osteoarticular diseases unrelated to T1DM or T2DM, (5) decrease or loss of vision that is difficult to treat or correct, (6) unstable cardiovascular disease or unstable ischemic cerebrovascular disease, (7) severe renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m2) or severe liver dysfunction (Child-Pugh grade C), (8) malignant tumor, (9) severe illness that would make 24-month survival unlikely (as judged by the patients physician), (10) pregnancy or breast-feeding women, (11) neurologic or psychiatric disease that may prevent compliance with the protocol, and (12) patients who are considered unsuitable for the trial by investigators.

Potential participants will be given a brief verbal explanation of the trial by their treating podiatrist. Research assistants will give them telephone interviews and invite patients who are willing to participate to our diabetic foot center for further confirming eligibility and baseline measurements. Written informed consent will be obtained by a trained and experienced podiatric nurse or podiatrist at the baseline visit. On the consent form, participants will be asked whether they agree to use of their data and biological specimens when they choose to withdraw from the trial and asked for permission for the research team to share their relevant data with people from the universities taking part in the research or from the regulatory authorities.

Note: The content above has been extracted from a research article, so it may not display correctly.

Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.

We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.