Status:
UNKNOWN
Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers
Lead Sponsor:
Assiut University
Conditions:
Stem Cell Transplant
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer
Detailed Description
Diabetic foot ulcers are a significant and rapidly growing complication of diabetes and its effects on wound healing. Over half of diabetic patients who develop a single ulcer will subsequently develo...
Eligibility Criteria
Inclusion
- Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU
- Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and chronic when the wound was treated with current standard care for diabetic foot ulcer by a wound care specialist for at least 3 months prior to the therapy with less than 40% of wound closure)
- Strict diabetes control with HbA1c ≤ 7.5%
- Grade 1 or 2 ulcer on the Wagner scale
Exclusion
- 1- Critical ischemia of the target limb, defined by pain at rest and an ankle systolic pressure \< 50 mm Hg, or a toe systolic pressure \< 30 mm Hg 2- DFU clinically infected as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other evidence of infection is present 3- Surgery or surgical revascularisation \< 2months 4- Collagen tissue diseases , malignant and hematological diseases onset of myocardial infarction or cerebral infarction within the last 6 months
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03259217
Start Date
October 1 2017
End Date
January 1 2019
Last Update
August 23 2017
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