The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer

NCT ID: NCT02972528

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-03
• Study Completion Date: 2020-09-30

Brief Summary

Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).

Detailed Description

In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct injection into the periphery of diabetic chronic foot ulcers which have not healed using standard of care. Investigators anticipate a significant response in treated individuals measured by the percentage of skin restoration achieved.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet Lysate

Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).

Group Type: ACTIVE_COMPARATOR

Platelet Lysate

Intervention Type: BIOLOGICAL

Direct injection of allogenic Platelet Lysate

Platelet Poor Plasma

Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3).

Group Type: PLACEBO_COMPARATOR

Platelet Poor Plasma

Intervention Type: BIOLOGICAL

Direct injection of allogenic Platelet Poor Plasma

Interventions

Platelet Lysate

Direct injection of allogenic Platelet Lysate

Intervention Type: BIOLOGICAL

Platelet Poor Plasma

Direct injection of allogenic Platelet Poor Plasma

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of at least 4 weeks duration

2. HemoglobinA1C (HbA1c) < 12

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 2 cm2 and 20 cm2, inclusive.

4. Wounds located under a Charcot deformity had to be free of acute changes and must have under gone appropriate structural consolidation.

5. The index ulcer had to be clinically non-infected and full - thickness without exposure of bone, ligaments, or tendons.

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 index (ABI).

8. Physical examination (including a Semmes-Weinstein monofilament test for neuropathy)

9. Blood tests to be obtained Complete Blood Count and HbA1c.

10. Approved, informed, signed consent.

11. Negative test for Hepatitis C (HC), Hepatitis B (HB), Human Immunodeficiency Virus 1 and 2 (HIVI and II), Venereal Disease Research Laboratory (VDRL).

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 ≥50% 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 randomization.

8. Patient has received growth factor therapy within 7 days of randomization.

9. Screening hemoglobin <10.5 mg/dL.

10. Screening platelet count < 100 x 109/L.

11. Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal platelet activation disorders - ie, gray platelet syndrome, liver disease, active cancer (except remote basal cell of the skin), eating/ nutritional,hematologic, collagen vascular disease, rheumatic disease, or bleeding disorders.

12. History of peripheral vascular repair within the 30 days of randomization

13. Patient has known or suspected osteomyelitis.

14. Surgical correction (other than debridement) required for ulcer to heal.

15. Index ulcer has exposed tendons, ligaments, muscle, or 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.

18. Patient has inadequate venous access for blood draw.

19. Positive test for HC, HB, HIVI and II, VDRL.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanan Jafar

OTHER

Sponsor Role: lead

Responsible Party

Hanan Jafar

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abdallah Awidi, MD

Role: STUDY_DIRECTOR

Cell Therapy Center

Locations

Cell Therapy Center

Amman, , Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Hanan Jafar, PhD

Role: CONTACT

hanan.jafar@gmail.com

00962798871087

Facility Contacts

Abdalla Awidi, MD

Role: primary

abdalla.awidi@gmail.com

0096265355000 ext. 23960

Other Identifiers

DFUUJCTC

Identifier Type: -

Identifier Source: org_study_id