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Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Laboratoires Genévrier.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Laboratoires Genévrier
ClinicalTrials.gov Identifier:
NCT00521937
First received: August 27, 2007
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost.

The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management.

Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively).

The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing.

A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily.

The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.


Condition Intervention Phase
Diabetes
Foot Ulcer
Other: Dermagen®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Multi-centre, Blind-observer, Controlled, Parallel-group Study Comparing the Efficacy and Safety of DERMAGEN® Versus Conventional Treatment in the Treatment of Diabetic Neuropathic Foot Ulcer

Resource links provided by NLM:


Further study details as provided by Laboratoires Genévrier:

Primary Outcome Measures:
  • Complete wound closure at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to complete wound healing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 388
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dermagen®
Other: Dermagen®
Weekly topical applications
Active Comparator: B
Conventional treatment
Other: Dermagen®
Weekly topical applications

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male patient aged ≥ 18
  • Patient with documented and stable* type I or II diabetes mellitus
  • With diagnosis of neuropathic foot ulcer located on the plantar surface of the forefoot
  • Ulcer with a surface area comprised between 1 and 15 cm2 included (after mechanical debridement of the ulcer)
  • Palpable pulse evidenced on both feet (presence of dorsalis pedis pulse and posterior tibial pulse) or in absence of one pulse, a Systolic Pressure Index (SPI) by Doppler > 0.9 on the target limb
  • Presence of diabetic foot ulcer for at least 4 weeks prior to enrolment
  • Patient's ulcer extending through the dermis without exposure of muscle, tendon, bone, or joint capsule *means confirmed by HbA1C at least every 4 months

Exclusion Criteria:

  • Typical Charcot's foot
  • Decrease or increase in the size of the ulcer by 50% or more during the run-in period
  • Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound (bone erosion or disappearance of the cortical bone))
  • Clinical evidence of Pedis grade 3, or 4 infection at the inclusion visit
  • Patient who cannot have an off-loading method
  • Patient with working activity who cannot be on sick-leave during the study period.
  • Patient presenting a known allergy to collagen, streptomycin, penicillin and/or products of bovine origin
  • Dialysed patient
  • Patient suffering from a psychiatric disorder not treated
  • Clinical evidence of gangrene on any part of the affected foot
  • Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521937

Locations
France
Marseille, France
Nancy, France
Nîmes, France
Paris, France
Roubaix, France
Thionville, France
Toulouse, France
Sponsors and Collaborators
Laboratoires Genévrier
Investigators
Study Chair: Olivier Chosidow, MD, PhD Hôpital Tenon, Paris
  More Information

No publications provided

Responsible Party: Fabien AUDIBERT, Laboratoires Genevrier
ClinicalTrials.gov Identifier: NCT00521937     History of Changes
Other Study ID Numbers: 06FB/DE02
Study First Received: August 27, 2007
Last Updated: December 14, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Foot Ulcer
Ulcer
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 25, 2014