Clinical study for efficacy and safety of bone marrow derived cell concentrate and allogenic dermal matrix complex therapy in diabetic foot ulcer
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009122
- Lead Sponsor
- Soon Chun Hyang University Hospital Bucheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 58
? Patients with intractable foot ulcers due to diabetes measuring between 2 x 2 cm² and less than 12 x 12 cm²
? Patients with diabetic foot ulcers that do not heal for 3 weeks despite conventional conventional wound treatment
? Patients with diabetic foot ulcers who have ABI <0.7 or who have undergone percutaneous angioplasty in cases where the wound exposes bone or tendon accompanied by infection.
? Adults over 19 years old, under 70 years old
? Those who signed the consent form after receiving an explanation of the purpose, methods, and effects of this study
? Those who have been diagnosed with a malignant blood disease such as lymphoma or leukemia and have not experienced remission
? People with severe anemia and other blood diseases
? Those who have a history of solid cancer or have been diagnosed with solid cancer and are currently undergoing chemotherapy
? Those who have undergone major surgical operations, organ biopsies, or significant trauma at the discretion of the researcher within 3 months prior to registration
? Those with active infection
? Those who are receiving or are scheduled to receive drugs that, as determined by the researcher, may affect the results
? Persons who are unable to comply with the research plan and follow-up observations
? Those who participated in another clinical trial within 30 days before registration
? A person who is deemed inappropriate by the researcher to participate in this study.
? Those currently taking steroids or immunosuppressants
? Persons who did not sign the written consent form for this clinical study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Black eschar, Eczema/dermatitis, Depth, Scarring, Color of wound bed, Oedema/Swelling, Resurfacing epithelium, and Exudate amount
- Secondary Outcome Measures
Name Time Method Degree of pain change: NRS (Numeric rating scale)