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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

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: adipose-derived regenerative cells (ADRCs) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diabetic foot ulcer Drug: adipose-derived regenerative cells (ADRCs)



Primary Outcome Measures :
  1. Percentage of patients achieving 100% wound closure [ Time Frame: 20 WEEKS ]

Secondary Outcome Measures :
  1. time to reach complete wound closure [ Time Frame: 20 WEEKS ]
  2. wound surface regression in relative value [ Time Frame: 20 weeks ]
  3. wound surface regression in absolute value [ Time Frame: 20 weeks ]
  4. percentage of patients achieving 50 % wound closure [ Time Frame: 20 weeks ]
  5. ulcer recurrence rate [ Time Frame: 20 weeks ]
  6. change in quality of life assessed by the SF-36 QoL survey from baseline [ Time Frame: 20weeks ]


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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:

  • 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

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): NCT02866565


Contacts
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Contact: PATRICE DARMON patrice.darmon@ap-hm.fr
Contact: alexandra GIULIANI alexandra.giliani@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France
Contact: PATRICE DARMON       patrice.darmon@ap-hm.fr   
Principal Investigator: PATRICE DARMON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: catherine GEINDRE Assistance Publique Hopitaux De Marseille
Principal Investigator: PATRICE DARMON Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866565     History of Changes
Other Study ID Numbers: 2016-41
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases