A clinical trial to evaluate the safety and efficacy of the pluripotent stem cell accumulating device (BSM1) and treatment of diabetic foot ulcers using Biiosheets
- Conditions
- Diabetic foot ulcers unhealed with standard treatment or requiring extra-resection of proximal sites
- Registration Number
- JPRN-jRCT2032230318
- Lead Sponsor
- Higashita Ryuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
(1) Age is over 18 years old
(2) Type 1 or type 2 diabetic mellitus
(3) Having an unhealed diabetic foot ulcer by standard wound treatment
(4) Chronic limb threatening ischemia that meets W-1 to 3, I-0 to 2, fI-0 to 2, and clinical stage 3 or 4 in WIfI classification
(5) Patients correspond to one of the following
a. Foot and/or heal ulcer allow for over 4cm2 wound area after the debridement
b. Foot gangrene allow for the additional resection including the healthy proximal site
(6) Survival of 12 months or more and followed-up for 12 weeks after the treatment are possible.
(7) Agreement for participating in the study and informed consent signed by the patient.
(1) Patients who have difficulty in securing the implantation period of the clinical trial equipment required for Biotube formation.
(2) Patients with general condition who are difficult to tolerate surgery due to severe malnutrition and complications.
(3) Patients with poor skin condition who cannot secure more than one implantation site for the investigational device.
(4) Patients undergoing invasive surgery except wound care (debridement) or revascularization within 30 days prior to enrollment
(5) Patients who have a history of allergies to stainless steel or polyolefin resin
(6) Poor control blood sugar level (Fasting blood sugar > 200 mg/dl)
(7) History and complications of malignant tumors (excludes those with no recurrence for more than 5 years after treatment or new onset).
(8) Participating in other clinical trials within 3 months prior to enrollment.
(9) History of experiences of this device or Biosheet
(10) Patients who use immunosuppressants for autoimmune diseases and post-implantation.
(11) Pregnant patients
(12) Large wounds allow for over 25cm2 area after the debridement.
(13) Severe limb ischemia having no options of revascularization or limb ischemia due to vasculitis.
(14) Progressive ulcers, gangrenes, and sepsis allow for major amputation.
(15) Septic conditions (CRP > 5 mg/dl)
(16) Patients judged by the investigator to be inappropriate due to medical conditions or safety reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of the patients (examinees) who were able to obtain the Biosheets containing pluripotent stem cells
- Secondary Outcome Measures
Name Time Method