A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

This prospective case series is to gain additional clinical experience in the treatment of diabetic foot ulcers, by documenting and relating patient history (including baseline wound characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient and physician satisfaction) in a group of study participants for whom the ReGenerCell™ Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings, offloading).

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: ReGenerCell™ Autologous Cell Harvesting Device

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Northwick Park Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital, London
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• The patient has stable diabetes mellitus according to investigators clinical judgement

• Diabetic foot Ulcer

  • Groups 1 and 2: Ulcer surface area between 3 cm2 and 100 cm2 (inclusive)
  • Group 1: 12-24 weeks in duration, no directly visible tendon or bone (University of Texas Ulcer grade 1A)
  • Group 2: >3 weeks in duration, University of Texas Ulcer grade 1B, 2A, 2B, 3A, 3B
• No superficial skin infection (of the ulcer area) requiring intervention
• Adequate offloading and compliance must be achievable
• The patient is 18 years of age or older
• The patient is willing to complete all follow-up evaluations required by the study protocol
• The patient is able to abstain from any other non-standard treatment of the ulcer for the duration of the study, unless medically necessary
• The patient agrees to abstain from enrolment in any other interventional clinical trial for the duration of the study
• The patient is able to read and understand instructions and give voluntary written informed consent
• The patient is able and willing to follow the protocol

Exclusion Criteria:

• Patients requiring intervention for Peripheral Arterial Disease (PAD) will be excluded from this study
• Severe Peripheral Arterial Disease that is not reconstructible
• Pregnant/lactating females (self-reported or tested, per institutional requirements
• Use of non-inert dressings (silver, honey etc.) during the past 10 days
• Subjects who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
• The patient is known to have a pre-existing active condition that may interfere with wound healing, e.g. malignancy, autoimmune disease, immunocompromised blood borne diseases, the patient has AIDS, is HIV- or Hepatitis-C positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
• The patient is taking, or has taken in the past 60 days, >10mg of corticosteroids per day.
• The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
• The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate solution.
• The patient is a vulnerable or protected adult
• The patient is unable to follow the protocol
• The patient is unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReGenerCell™; Debridement and/or a sterile saline rinse of ulcer, as clinically indicated, followed by ReGenerCell™ treatment and appropriate dressing and off-loading	Device: ReGenerCell™ Autologous Cell Harvesting Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Closure	100% Re-epithelialisation of wound	26 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound size	Objectively measured ulcer area cmxcm	26 Weeks
Neuro-QoL	Quality of Life short questionnaire	26 Weeks

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 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: CTP005