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Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous Adipose-derived REGEnerative Cells in the Local Treatment of Neuropathic Diabetic Foot ulcERs (REGENDER)

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ClinicalTrials.gov Identifier: NCT02866565
Recruitment Status : Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date August 15, 2016
Study Start Date  ICMJE February 2017
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Percentage of patients achieving 100% wound closure [ Time Frame: 20 WEEKS ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • time to reach complete wound closure [ Time Frame: 20 WEEKS ]
  • wound surface regression in relative value [ Time Frame: 20 weeks ]
  • wound surface regression in absolute value [ Time Frame: 20 weeks ]
  • percentage of patients achieving 50 % wound closure [ Time Frame: 20 weeks ]
  • ulcer recurrence rate [ Time Frame: 20 weeks ]
  • change in quality of life assessed by the SF-36 QoL survey from baseline [ Time Frame: 20weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous Adipose-derived REGEnerative Cells in the Local Treatment of Neuropathic Diabetic Foot ulcERs
Official Title  ICMJE Not Provided
Brief Summary

Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors, healing rates of DFU remain low.

Mechanisms of faulty wound healing in diabetic patients are complex, related to both intrinsic and extrinsic factors. The main reasons for impaired healing appears to be: 1/exhaustion of local cell populations that promote wound healing; 2/excessive production of matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor cells and impairment of their functioning. These imbalances may result in excessive degradation of extracellular matrix components, as well as an inappropriate local inflammatory response .

Adipose-derived stroma vascular fraction provides a rich and easily accessible source of autologous cells for regenerative medicine applications. Il contains multipotent stem cells and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound healing. There are attracted to the wound site where they supplement the wound bed with similar cell types, secrete numerous growth factors and cytokines, increase macrophage recruitment, enhance granulation tissue, and improve vascularisation . The reparative capabilities coupled with good safety of ADRCs have been illustrated in a study for treating severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly in patients with diffuse scleroderma. Numerous case reports showing healing of refractory wounds following treatment with autologous ADRCs have also been reported.

Based on these previous reports, the present study aims to assess the efficacy and tolerance of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Drug: adipose-derived regenerative cells (ADRCs)
Study Arms  ICMJE Experimental: Diabetic foot ulcer
Intervention: Drug: adipose-derived regenerative cells (ADRCs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient older than 18
  • Patient with type 1 or 2 diabetes mellitus with HbA1C level < 10%
  • Patient with diagnosis of neuropathic or neuro-ischemic DFU
  • Grade 1 or 2 ulcer on the Wagner scale
  • Ulcer with a surface area comprised between 1 cm2 and 15 cm2 at day 0 Patient present for a minimum of 4 weeks under the current investigator's care including adequate wound debridement and offloading
  • Semmes-Weinstein monofilament test indicating neuropathy
  • DFU located on the toe or on the lateral, dorsal surface of the forefoot or heel

Exclusion Criteria:

  • Pregnant or likely to become pregnant or breast feeding woman
  • Critical ischemia of the target limb, defined by pain at rest and an ankle systolic pressure < 50 mm Hg, or a toe systolic pressure < 30 mm Hg
  • Surgery or surgical revascularisation < 2months
  • Decrease or increase in the ulcer size by 30% or more within a 2-wk run-in period
  • DFU clinically infected as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other evidence of infection is present Dossier LIC-15-15-0005 REGENDER Déposé le 09/03/2015 15:22:11 par M. Patrice DARMON Appel LIC-15-2015 Page 3 sur 6
  • Patient who cannot bear an off-loading method
  • Patient with an active neoplasm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: PATRICE DARMON patrice.darmon@ap-hm.fr
Contact: alexandra GIULIANI alexandra.giliani@ap-hm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866565
Other Study ID Numbers  ICMJE 2016-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: catherine GEINDRE Assistance Publique Hopitaux De Marseille
Principal Investigator: PATRICE DARMON Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP