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

Phase 4

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: ReGenerCell™ Autologous Cell Harvesting Device

• Registration Number: NCT02799121
• Lead Sponsor: Avita Medical

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Complete Wound Closure	26 Weeks	100% Re-epithelialisation of wound

Secondary Outcome Measures

Name	Time	Method
Neuro-QoL	26 Weeks	Quality of Life short questionnaire
Wound size	26 Weeks	Objectively measured ulcer area cmxcm

Trial Locations

Locations (3)

King's College Hospital, London; 🇬🇧 London, United Kingdom

Northwick Park Hospital; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom