Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers

NCT06825884 | Active Not Recruiting Phase 1

• 2 other identifiers: EVDFUUJCTCUniversity of Jordan
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• To determine the short-term speed and effectiveness of extracellular micro vesicles (EV) on the healing of diabetic foot ulceration. And to prove that extracellular micro vesicles (EV) will significantly shorten the required timeto heal DFU.

  After measuring the wound area surface * the investigators will consider that the wound is full-healed when its surface area is healed (100%) * the investigators will consider that the wound is partial-healed when its surface area is healed (50- 100%) * the investigators will consider that the wound is minimal-healed when its surface area is healed (25- 50%) * the investigators will consider that the wound is non-healed when its surface area is \<25%

  follow-up duration is 12 months

Study Arms (1)

Extracellular vesicles (EV)

EXPERIMENTAL

* Patients will receive 5 ml perilesional injections as treatment weekly interval. * Post injection dressing will be with exofiber and bandaging. * Off-loading will apply when required. * Quantitative ulcer healing will be calculated according the surface area of the remaining ulcer at week 10 and12. * Standard of care will be given throughout the whole study period from week 1 through week 12.

Biological: Extracellular micro vesicles (EV)

Interventions

Extracellular micro vesicles (EV) BIOLOGICAL

Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.

Extracellular vesicles (EV)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Ulcer decreased (up to) 25% in area during 7-day screening period.
• Ulcer is due to non-diabetic etiology.
• Patient's blood vessels are non-compressible for ABI testing.
• Evidence of gangrene in ulcer or on any part of the foot.
• Patient has radiographic evidence consistent with diagnosis of acute Charcot foot.
• Patient is currently receiving or has received radiation or chemotherapy within 3 months of treatment.
• Patient has received growth factor therapy within 7 days of treatment.
• Screening hemoglobin \&lt;10.0 mg/dL.
• Screening platelet count \&lt; 100 x 10 9 /L.
• 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.
• History of peripheral vascular repair within the 30 days.
• Patient has known or suspected osteomyelitis.
• Surgical correction (other than debridement) required for ulcer to heal.
• Index ulcer has exposed bone.

Sponsors & Collaborators

• University of Jordan: lead
• Abdalla Awidi Abbadi, MD: collaborator

Study Sites (1)

Cell Therapy Center

Amman, 00962, Jordan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 13, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

JO (1)