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

Primary Purpose

Diabetes, Foot Ulcer

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Dermagen®

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Dermagen®

Conventional treatment

Outcomes

Primary Outcome Measures

Complete wound closure at week 12

Secondary Outcome Measures

Time to complete wound healing

Full Information

NCT ID

NCT00521937

First Posted

August 27, 2007

Last Updated

December 14, 2010

Sponsor

Laboratoires Genévrier

1. Study Identification

Unique Protocol Identification Number

NCT00521937

Brief Title

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

Acronym

DERMAGEN®

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratoires Genévrier

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Dermagen®

Arm Title

Arm Type

Active Comparator

Arm Description

Conventional treatment

Intervention Type

Other

Intervention Name(s)

Dermagen®

Intervention Description

Weekly topical applications

Primary Outcome Measure Information:

Title

Complete wound closure at week 12

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Time to complete wound healing

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Chosidow, MD, PhD

Organizational Affiliation

Hôpital Tenon, Paris

Official's Role

Study Chair

Facility Information:

City

Marseille

Country

France

City

Nancy

Country

France

City

Nîmes

Country

France

City

Paris

Country

France

City

Roubaix

Country

France

City

Thionville

Country

France

City

Toulouse

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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