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

NCT02972528 | Unknown Phase 1 DMC

• 1 other identifier: DFUUJCTC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Keywords

DFU; Diabetic Foot Ulcer; Diabetes; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection

  Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.

  3 months

Secondary Outcomes (1)

• Assess the efficacy of allogenic Platelet Lysate injection by clinical examination

  4 months

Study Arms (2)

Platelet Lysate

ACTIVE COMPARATOR

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

Platelet Poor Plasma

PLACEBO COMPARATOR

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

Interventions

Platelet Lysate BIOLOGICAL

Direct injection of allogenic Platelet Lysate

Platelet Lysate

Platelet Poor Plasma BIOLOGICAL

Direct injection of allogenic Platelet Poor Plasma

Platelet Poor Plasma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of at least 4 weeks duration
• HemoglobinA1C (HbA1c) \< 12
• 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.
• Wounds located under a Charcot deformity had to be free of acute changes and must have under gone appropriate structural consolidation.
• The index ulcer had to be clinically non-infected and full - thickness without exposure of bone, ligaments, or tendons.
• The protocol requires that post debridement the ulcer would be free of necrotic debris, foreign bodies or sinus tracts.
• Non- invasive vascular testing ankle brachial index (ABI).
• Physical examination (including a Semmes-Weinstein monofilament test for neuropathy)
• Blood tests to be obtained Complete Blood Count and HbA1c.
• Approved, informed, signed consent.
• Negative test for Hepatitis C (HC), Hepatitis B (HB), Human Immunodeficiency Virus 1 and 2 (HIVI and II), Venereal Disease Research Laboratory (VDRL).

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 ≥50% 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 randomization.
• Patient has received growth factor therapy within 7 days of randomization.
• Screening hemoglobin \<10.5 mg/dL.
• Screening platelet count \< 100 x 109/L.
• 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.
• History of peripheral vascular repair within the 30 days of randomization
• Patient has known or suspected osteomyelitis.
• Surgical correction (other than debridement) required for ulcer to heal.
• Index ulcer has exposed tendons, ligaments, muscle, or bone.

Sponsors & Collaborators

• Hanan Jafar: lead

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Abdallah Awidi, MD

  Cell Therapy Center

  STUDY DIRECTOR

Central Study Contacts

Hanan Jafar, PhD

CONTACT

00962798871087; hanan.jafar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: February 3, 2018
• Primary Completion: February 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

JO (1)