Total Contact Cast for intractable foot ulceration in diabetic patients Registry, a Prospective, Multicenter Study in Japan With 3-Month Follow-up
- Conditions
- on-healing Foot Ulcer
- Registration Number
- JPRN-UMIN000012694
- Lead Sponsor
- Saga University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1.Presence of ulcers in both the forefoot and the heel. 2.Local infection on the ulcer area and/or systemic infection. 3.In the case of bone exposure or radiographic signs of myelitis.findings. 4.Negative arterial Doppler examination for the dorsalis pedis artery and/or the posterior tibial artery due to critical limb ischemia. 5.Plantar ulcers exist bilaterally or the contralateral foot has been amputated. 6.Malignant tumor exists in the wound bed or its surroundings. 7.Uncontrollable bleeding from the wound. 8.Deep venous thrombosis, varicose veins, or lymphedema. 9.Radiation therapy, chemotherapy, VEGF inhibitor, or administration of steroids. 10.Poor general status, under-nutrition, coagulopathy, or connective tissue disease. 11.A pregnant or breast-feeding woman or a child. 12.Patients who cannot come to our hospital. 13.Patients judged to be inappropriate for enrollment in this study.
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method