Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers
Sponsored by University of Jordan
About this trial
Last updated a year ago
Study ID
EVDFUUJCTC
Status
Active not recruiting
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
30 to 75 Years
All Sexes
Trial Timing
Started 2 years ago
What is this trial about?
Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes related lower leg amputations are anticipated to the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.
What are the participation requirements?
Inclusion Criteria
Persons with type 2 diabetes between the ages of 30 and 75 with an ulcer of at least 6 weeks' duration. 2. Hemoglobin A1C< 11. 3. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces); and wound area (length x width) measurement between 1 cm 2 and 60 cm 4. Wounds located under a Charcot deformity should be free of acute changes and must have undergone appropriate structural consolidation. 5. The index ulcer should be clinically non-infected and full-thickness without exposure of bone. 6. The protocol requires that post debridement; the ulcer would be free of necrotic debris, foreign bodies or sinus tracts. 7. Non- invasive vascular testing ankle brachial pressure index (ABPI) < 0.80. 8. Physical examination (including a Semmes-Weinstein monofilament test for neuropathy using the 5.07/10 g monofilament to test the plantar aspects of the great toe, third, and fifth metatarsal heads. 9. Negative for infectious panel (HIV, HBV, HCV, and VDRL). 10. Approved signed informed consent. 11. Coding and Randomization.
Exclusion Criteria
1. Patient currently enrolled in another investigational device or drug trial or previously enrolled (within last 30 days) in investigative research of a device or pharmaceutical agent.
2. Ulcer decreased (up to) 25% in area during 7-day screening period.
3. Ulcer is due to non-diabetic etiology.
4. Patient's blood vessels are non-compressible for ABI testing.
5. Evidence of gangrene in ulcer or on any part of the foot.
6. Patient has radiographic evidence consistent with diagnosis of acute Charcot foot.
7. Patient is currently receiving or has received radiation or chemotherapy within 3 months of treatment.
8. Patient has received growth factor therapy within 7 days of treatment.
9. Screening hemoglobin <10.0 mg/dL.
10. Screening platelet count < 100 x 10 9 /L.
11. Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal platelet activation disorders, eating/ nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorders.
12. History of peripheral vascular repair within the 30 days.
13. Patient has known or suspected osteomyelitis.
14. Surgical correction (other than debridement) required for ulcer to heal.
15. Index ulcer has exposed bone.
16. Patient is known to have a psychological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with compliance with study requirements and/or healing of the ulcer.
17. History of alcohol or drug abuse within the last year prior to randomization.