MARTORELL'S ULCERPhase 3ERANNCT00970697
Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers
A Phase 3 study testing becaplermin gel and Duoderm Hydrogel™ in people with MARTORELL'S ULCER and Hypertensive Leg Ulcer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial. Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MARTORELL'S ULCER, Hypertensive Leg Ulcer, Necrotic Angiodermatitis
- What is being tested?
- becaplermin gel and Duoderm Hydrogel™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Jun 2009
- 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
- patients 18 years of age or older, able to give informed consent and to follow the treatment procedure
- target ulcer area between 1 and 30 cm2
- consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers
- presence of an arterial hypertension, according to the WHO criteria, treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet
- absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis
- absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index ≥0.8
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- absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain
- superficial spreading necrotic ulcer
- presence of spontaneous pain
- presence of a red purpuric margin
Who cannot join
- pregnancy
- allergy to hydrogel or to becaplermin gel
- uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder
- presence of a cryoglobulinemia
- serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment)
- concomitant treatment by ILOMEDINE
- bone, joint or tendon (except for achilles tendon) exposition in the wound
- systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.
Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.
Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.
Read more
Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.
Primary aim of the study: Complete closure at week 8
Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment
Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed
Read the detailed description
Hypertensive leg ulcers are a variety of leg ulcer characterized by very painful and spreading lesions, related to cutaneous microangiopathy, occurring in patients presenting hypertension and /or diabetes. Healing takes a mean of 4 to 12 months. Current treatment is difficult and usually surgical (pinch or meshed skin grafts). Growth factors release by autografted skin may be a significant factor in the promotion of hypertensive leg ulcer healing. Recombinant human platelet derived growth-factor-BB gel (becaplermin gel) has been shown to be effective in the treatment of diabetic ulcers related to diabetic microangiopathy. The objective of the study was to assess the efficacy of becaplermin gel for the healing of hypertensive leg ulcers. Study design: prospective, randomized, multi-centre, double blind, controlled, parallel groupPrimary aim: complete wound closure at week 8Secondary aims: complete wound closure at week 12, pain and quality of life assessment during the treatment( W4,8,10,12), % of wound area reduction at week 8 and 12 Method: Inclusion of 64 patients, 32 in each group. The study population consisted of consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers: hypertensive and/or diabetic patients, in absence of chronic venous insufficiency (C5-C6 of the CEAP) or peripheral arterial occlusive disease (presence of peripheral pulses or ankle brachial index ≥0.8), superficial spreading necrotic ulcer, presence of spontaneous pain, and presence of a red purpuric margin. Treatment consists of a daily application of a continuous thin layer of becaplermin gel (Regranex Gel®) or Duoderm Hydrogel™, during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion (as recommended for Regranex gel®), and remains identical during all the treatment. Wound was then recovered by a moist saline gauze and a bandage. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient.At week 8, a pinch graft was proposed to patients whom the ulcer was not healed. Between weeks 8 and 12, if patient had not healed and was not grafted, dressing was chosen by the investigator, depending on the wound stage. All patients were followed until week 12.
- Being tested
- becaplermin gel, Duoderm Hydrogel™
- Keywords
- MARTORELL'S ULCER, hydrogel, Hypertensive leg ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
becaplermin gelDrug
the amount of the gel to be applied was determined based on ulcer area at inclusion and remains identical during all the treatment The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Becaplermin gel is packaged into masked 15g-tubes.
Duoderm Hydrogel™Drug
The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Hydrogel dressing is identical in appearance, color, consistency, and odor than becaplermin gel, and packaged in similar masked15g-tubes.
| Study group | Role | What they receive |
|---|---|---|
| becaplermin gel | Experimental | application of a continuous thin layer of becaplermin gel (Regranex Gel®) during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. Receives: Drug: becaplermin gel |
| Duoderm Hydrogel™ | Active comparator | application of a continuous thin layer of hydrogel dressing (Duoderm Hydrogel®), during 8 weeks. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient. Receives: Drug: Duoderm Hydrogel™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure rate at week 8 of treatment
Measured: week 9
Secondary outcomes (4)
Complete wound closure rate at week 12 of treatment
Measured: week 13
pain and quality of life evolution during the treatment( W4,8,10,12),
Measured: week 9
% of wound area reduction at week 8 and 12
Measured: weeks 9 and 13
safety of the treatment at week 4, 8 and 12
Measured: week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJan 2004
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MARTORELL'S ULCERStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia SENET, Principal investigator, Dermatology, Charles Foix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970697
- Sponsor's protocol ID
- P020706
- Acronym
- ERAN
- Status last verified
- Sep 2011
- First submitted
- 1 Sep 2009
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.
PubMed 21482863
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.
- ClinicalTrials.gov ID
- NCT00970697
- Acronym / sponsor ID
- ERAN / P020706
- Keywords
- MARTORELL'S ULCER, hydrogel, Hypertensive leg ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Sep 2009 (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.
Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.
Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.
Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.
Primary aim of the study: Complete closure at week 8
Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment
Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed
Detailed description
Hypertensive leg ulcers are a variety of leg ulcer characterized by very painful and spreading lesions, related to cutaneous microangiopathy, occurring in patients presenting hypertension and /or diabetes. Healing takes a mean of 4 to 12 months. Current treatment is difficult and usually surgical (pinch or meshed skin grafts). Growth factors release by autografted skin may be a significant factor in the promotion of hypertensive leg ulcer healing. Recombinant human platelet derived growth-factor-BB gel (becaplermin gel) has been shown to be effective in the treatment of diabetic ulcers related to diabetic microangiopathy. The objective of the study was to assess the efficacy of becaplermin gel for the healing of hypertensive leg ulcers. Study design: prospective, randomized, multi-centre, double blind, controlled, parallel groupPrimary aim: complete wound closure at week 8Secondary aims: complete wound closure at week 12, pain and quality of life assessment during the treatment( W4,8,10,12), % of wound area reduction at week 8 and 12 Method: Inclusion of 64 patients, 32 in each group. The study population consisted of consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers: hypertensive and/or diabetic patients, in absence of chronic venous insufficiency (C5-C6 of the CEAP) or peripheral arterial occlusive disease (presence of peripheral pulses or ankle brachial index ≥0.8), superficial spreading necrotic ulcer, presence of spontaneous pain, and presence of a red purpuric margin. Treatment consists of a daily application of a continuous thin layer of becaplermin gel (Regranex Gel®) or Duoderm Hydrogel™, during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion (as recommended for Regranex gel®), and remains identical during all the treatment. Wound was then recovered by a moist saline gauze and a bandage. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient.At week 8, a pinch graft was proposed to patients whom the ulcer was not healed. Between weeks 8 and 12, if patient had not healed and was not grafted, dressing was chosen by the investigator, depending on the wound stage. All patients were followed until week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| becaplermin gel | Experimental | Drug: becaplermin gelapplication of a continuous thin layer of becaplermin gel (Regranex Gel®) during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. |
| Duoderm Hydrogel™ | Active comparator | Drug: Duoderm Hydrogel™application of a continuous thin layer of hydrogel dressing (Duoderm Hydrogel®), during 8 weeks. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients 18 years of age or older, able to give informed consent and to follow the treatment procedure
- target ulcer area between 1 and 30 cm2
- consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers
- presence of an arterial hypertension, according to the WHO criteria, treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet
- absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis
Key exclusion criteria (8 listed)
- pregnancy
- allergy to hydrogel or to becaplermin gel
- uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder
- presence of a cryoglobulinemia
- serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment)
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 |
|---|---|---|
| becaplermin gelthe amount of the gel to be applied was determined based on ulcer area at inclusion and remains identical during all the treatment The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Becaplermin gel is packaged into masked 15g-tubes. | Drug | becaplermin gel |
| Duoderm Hydrogel™The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Hydrogel dressing is identical in appearance, color, consistency, and odor than becaplermin gel, and packaged in similar masked15g-tubes. | Drug | Duoderm Hydrogel™ |
Primary outcome
Complete wound closure rate at week 8 of treatment
Time frame: week 9
4 secondary outcomes
Complete wound closure rate at week 12 of treatment
Time frame: week 13
pain and quality of life evolution during the treatment( W4,8,10,12),
Time frame: week 9
% of wound area reduction at week 8 and 12
Time frame: weeks 9 and 13
safety of the treatment at week 4, 8 and 12
Time frame: week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- Derived from this study: PubMed 21482863Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.
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.
Patricia SENET principal investigator
Dermatology, Charles Foix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing becaplermin gel and Duoderm Hydrogel™ in people with MARTORELL'S ULCER and Hypertensive Leg Ulcer, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate at week 8 of treatment (time frame: week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970697, which also lists 1 linked publication.
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 4 Oct 2011.