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

Study Overview
=================
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).

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

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Device: ReGenerCell™ Autologous Cell Harvesting Device


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReGenerCell™<br>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<br> <br> |

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 |