Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

NCT02989961 | Unknown Phase 1 DMC

• 1 other identifier: Resticutis.UJCTC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.

Conditions

Diabetic Foot Ulcer

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.

  2 months

Secondary Outcomes (1)

• Assess the efficacy of autologous Resticutis injection by clinical examination

  4 months

Study Arms (2)

A-Resticutis

EXPERIMENTAL

Autologous, Activated-Platelets type of preparation.

Other: Resticutis

C-Platelet-Poor Plasma PPP

PLACEBO COMPARATOR

Platelet-Poor Plasma type of preparation achieved by centrifugation of blood samples at high speed conditions. Resticutis is administered instead if the patient doesn't achieve full healing after 6 injections.

Other: Resticutis; Other: Platelet-Poor Plasma (PPP)

Interventions

Resticutis OTHER

Autologous, Activated-Platelets type of Preparation

Also known as: Actiplate 1

A-Resticutis; C-Platelet-Poor Plasma PPP

Platelet-Poor Plasma (PPP) OTHER

A preparation of low platelet plasma obtained by a high-speed centrifugation step.

C-Platelet-Poor Plasma PPP

Eligibility Criteria

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

You may qualify if:

• People with Type II Diabetes mellitus between the ages of 18 and 70 with an ulcer with at least 4 weeks duration.
• Hb1c of less than 13 %.
• Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces), and wound area (length\*width) measurement between 0.5 cm\^2 and 20 cm\^2, inclusive.
• Wounds located under a Charcot deformity has to be free of acute changes and went through appropriate structural consolidation.
• Wagner Grade II or III ulcer.
• 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 (CBC, Hb1c)
• Approved, informed, signed consent to be obtained from each patient.

You may not qualify if:

• Patient currently enrolled in another investigative device or drug trial or previously enrolled (within the last 30 days) in an investigative research of a device or a pharmaceutical agent.
• Ulcer area decreased \> 50% during the seven-day screening period.
• Ulcer is due to a non-diabetic etiology.
• Evidence of gangrene in ulcer or on any part of the foot.
• Patient is currently receiving or has received radiation or chemotherapy within the last 3 months of randomization.
• Patient has received growth factor therapy within 7 days of randomization.
• Screening platelets count \< 100\* 10\^9/L.
• Patient is undergoing renal dialysis, or has a known immune insufficiency, known abnormal platelets activation disorder (i.e. Grey Platelet Syndrome, Liver Disease, Active Cancer), eating/nutritional, hematologic, collagen vascular disease, rheumatic disease, or bleeding disorder.
• History of peripheral vascular repair within 30 days of randomization.
• Patient is known to have a physiological, developmental, physical, emotional, or social disorder, or any other situation that may interfere with their compliance with the study requirements and/or the healing of the ulcer.
• History of alcohol or drug abuse within the last year prior to randomization.
• Patient has inadequate venous access for blood withdraw.

Sponsors & Collaborators

• Hanan Jafar: lead

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 Design

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

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 12, 2016
• Study Start: November 15, 2013
• Primary Completion: March 13, 2018
• Study Completion: November 1, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share