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

NCT02402374 | Unknown FDA Device

• 1 other identifier: 2014-WH-02
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PRP gel

EXPERIMENTAL

Autologous platelet rich plasma gel

Device: Autologous platelet rich plasma gel

Placebo

PLACEBO COMPARATOR

Saline gel

Device: Placebo

Interventions

Autologous platelet rich plasma gel DEVICE

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

PRP gel

Placebo DEVICE

Placebo control arm will be receiving commercial formulations of pre-prepared saline gel.

Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regen Lab SA: lead
• RegenLab USA LLC: collaborator

Study Sites (1)

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Alisha Oropallo, MD

  Northwell Health, Comprehensive Wound Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: April 12, 2018
• Primary Completion: October 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 8, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)