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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02799121
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: ReGenerCell™ Autologous Cell Harvesting Device Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
Study Start Date : May 2016
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Complete Wound Closure [ Time Frame: 26 Weeks ]
    100% Re-epithelialisation of wound


Secondary Outcome Measures :
  1. Wound size [ Time Frame: 26 Weeks ]
    Objectively measured ulcer area cmxcm

  2. Neuro-QoL [ Time Frame: 26 Weeks ]
    Quality of Life short questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799121


Locations
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United Kingdom
King's College Hospital, London
London, United Kingdom, SE5 9RS
Northwick Park Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Avita Medical
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT02799121    
Other Study ID Numbers: CTP005
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases