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

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ClinicalTrials.gov Identifier: NCT02972528
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hanan Jafar, University of Jordan

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: Platelet Lysate Biological: Platelet Poor Plasma Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer
Actual Study Start Date : February 3, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Platelet Lysate
Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).
Biological: Platelet Lysate
Direct injection of allogenic Platelet Lysate

Placebo Comparator: 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).
Biological: Platelet Poor Plasma
Direct injection of allogenic Platelet Poor Plasma




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection [ Time Frame: 3 months ]
    Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.


Secondary Outcome Measures :
  1. Assess the efficacy of allogenic Platelet Lysate injection by clinical examination [ Time Frame: 4 months ]
    To determine short term speed and effectiveness of allogeneic, platelet rich plasma lysate on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the diameter of ulcers.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972528


Contacts
Contact: Hanan Jafar, PhD 00962798871087 hanan.jafar@gmail.com

Locations
Jordan
Cell Therapy Center Recruiting
Amman, Jordan, 11942
Contact: Abdalla Awidi, MD    0096265355000 ext 23960    abdalla.awidi@gmail.com   
Sponsors and Collaborators
Hanan Jafar
Investigators
Study Director: Abdallah Awidi, MD Cell Therapy Center

Responsible Party: Hanan Jafar, Researcher, University of Jordan
ClinicalTrials.gov Identifier: NCT02972528     History of Changes
Other Study ID Numbers: DFUUJCTC
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanan Jafar, University of Jordan:
DFU
Diabetic Foot Ulcer
Diabetes
Platelet Rich Plasma

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases