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

Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Age Range:18 - 95
Start Date:April 12, 2018
End Date:September 30, 2019
Contact:Jacqueline Whetteckey, MD

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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).

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

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

- 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

- 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

- Patients with active Charcot or other structural deformity that would prevent adequate
off-loading of the study foot
We found this trial at
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Mark McKenzie, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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