DiabetesPhase 3DERMAGEN®NCT00521937
Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer
A Phase 3 study testing Dermagen® in people with Diabetes and Foot Ulcer, run by Laboratoires Genévrier at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer
- What is being tested?
- Dermagen®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Study site
Marseille
Study site
Nancy
Study site
Nîmes
Study site
Paris
Study site
Roubaix
Study site
Thionville
Study site
Toulouse
About this study
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
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.
Read more
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.
- Conditions
- Diabetes, Foot Ulcer
- Being tested
- Dermagen®
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermagen®Other
Weekly topical applications
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dermagen® Receives: Other: Dermagen® |
| B | Active comparator | Conventional treatment Receives: Other: Dermagen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure at week 12
Measured: 12 weeks
Secondary outcomes (1)
Time to complete wound healing
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startJan 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Genévrier
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Olivier Chosidow, MD, PhD, Study chair, Hôpital Tenon, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521937
- Sponsor's protocol ID
- 06FB/DE02
- Acronym
- DERMAGEN®
- Status last verified
- Dec 2010
- First submitted
- 27 Aug 2007
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00521937
- Acronym / sponsor ID
- DERMAGEN® / 06FB/DE02
- Conditions
- Diabetes, Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Laboratoires GenévrierIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Dermagen®Dermagen® |
| B | Active comparator | Other: Dermagen®Conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermagen®Weekly topical applications | Other | A, B |
Primary outcome
Complete wound closure at week 12
Time frame: 12 weeks
1 secondary outcome
Time to complete wound healing
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Chosidow, MD, PhD study chair
Hôpital Tenon, Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermagen® in people with Diabetes and Foot Ulcer, run by Laboratoires Genévrier at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.