Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer

Randomized, Placebo-controlled, Blind-assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared With the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer

Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: Autologous platelet rich plasma gel; Device: Placebo

Detailed Description

Evaluate the safety and efficacy of RegenKit autologous PRP Gel for the treatment of diabetic foot ulcer is a randomized, placebo controlled, blind-assessor study. One hundred and seventy four patients will be treated, 87 patients receiving treatment arm and 87 patients receiving placebo. The primary endpoint is to evaluate proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel) treated patients with complete wound closure at the same time-point.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Patients who in the opinion of the Investigator, are capable of understanding and complying with protocol requirements
• Patients or, when applicable, their legal representatives, sign and dates a written IFC and/or any required privacy authorization prior to the initiation of any study procedure
• Patients aged 18 to 95 (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
• Patients with glycated hemoglobin (HbA1C) less than or equal to 12%
• Patients having ulcers which meet the following criteria:
• Ulcer should not be infected as determined by clinical examination
• Ulcer duration of 4 weeks or longer
• Ulcer area (length x width) of between 1.5 cm2 and 20 cm2
• Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's classification system
• Ulcer has undergone recent debridement (2 weeks prior to screening)
• Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining and is comprised of healthy vascularized tissue
• Patients with Charcot deformity, the wound should be free of acute changes and, in the opinion of Investigator, should have undergone appropriate structural consolidation (the affected charcot fractures will have been fused together and should be sufficiently stable to allow the patient to weight-bear)

• Patients having adequate circulation to the foot as documented by either:

  1. Ankle Brachial Index (ABI) between 0.60 and 1.30, or
  2. Patients with falsely elevated ABI values (equal to or greater than 1.30) due to non-compressible ankle vessels:

  i)Toe Brachial Index (TBI) equal to or greater than 0.50 or, ii)TBI is not available (toe is absent, wounds are present, or investigative site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g duplex imaging or normal pulse volume recording)

• Patients who agree to conform to the off-loading requirements
• Patients of childbearing age must agree to use a method of contraception or agree to abstain from sexual intercourse throughout the study

Exclusion Criteria

• Patients with ulcers having an active infection with/without purulent discharge
• Patients with ulcers with exposed bone or associated with osteomyelitis
• Patients with target limb cellulitis, or ischemic or gangrenous ulcers
• Patients who have undergone, in the 2-week period prior to enrollment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments
• Female patients who are pregnant or lactating
• Patients diagnosed with cancer, undergoing chemotherapy, except basal cell carcinoma
• Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision
• Patients with wounds due to malignancy
• Patients having had any revascularization surgery within the 4-week period prior to signing the ICF
• Patients with renal failure requiring dialysis
• Patients with platelet count outside of the normal range of 150-400 x 1000/uL
• Patients with a history of allergy to one of tested components
• Patients with a history of bleeding disorders
• Patients suffering from skin or blood cancers, or having suffered in the past from such cancers and not having, certification of a total remission
• Patients presenting skin lesions potentially caused by abnormal cellular proliferation process (history of being cancerous)
• Patients with a history of any condition, physical examination finding, or clinical laboratory finding, giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational agent or may confound the interpretation of study results or might render the patient at high risk for treatment complications
• Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP gel; Autologous platelet rich plasma gel	Device: Autologous platelet rich plasma gel; PRP gel application to exuding wounds, such as leg ulcers, pressure ulcers, and diabetic foot ulcers and for the management of mechanically- or surgically-debrided wounds
Placebo Comparator: Placebo; Saline gel	Device: Placebo; Placebo control arm will be receiving commercial formulations of pre-prepared saline gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with complete wound closure	Proportion of patients with complete wound closure at week 16 when treated with autologous platelet rich plasma gel compared to the proportion of control (saline gel)-treated patients with complete wound closure at the same time-point.	16 weeks

Collaborators and Investigators

• Sponsor: Regen Lab SA
• Collaborators: RegenLab USA LLC
• Investigators: Principal Investigator: Alisha Oropallo, MD, Northwell Health, Comprehensive Wound Care Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 2014-WH-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Institution and the Principal Investigator are free to publish, present, or use any data and results arising out of this Study, provided that such publication does not disclose any of Sponsor's Confidential Information. Sponsor shall be able to present data and results at symposia, national or regional professional meetings, and publish in journals, theses or dissertations, or otherwise of its own choosing. In the event that the Principal Investigator fails to submit a formal academic publication within twelve (12) months following completion of the Study, the Sponsor is entitled to prepare a publication based on the data and results. Such proposed publication will be submitted to the Institution for review and comment at the least thirty (30) calendar days before submission for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No