Skin UlcerAngiolipoNCT01932021
Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting
A study testing adipose tissue grafting in people with Skin Ulcer, run by University Hospital, Caen at 1 site in France.
Trial summary
The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol crystal emboli, vasculitis associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer
- What is being tested?
- adipose tissue grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Dec 2014
- Phase
- Interventional
- 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 over 18 years with a necrotic ulcer or angiodermatitis Martorell.
- Recipient of the system of social security.
- Ulceration sudden onset peripheral Livedoid border, on superficial leg without bone or tendon exposure.
- IPS Index (systolic pressure)> 0.8 with pedal pulses.
- Wound area less than 300 cm2 surface measurement with Canvas ® software from a photograph of the wound next to which there is a calibration strip.
- Patients with hypertension.
- Patient was informed of the study and having signed an informed consent.
Who cannot join
- Severe distal arteritis (arteritis of large arteries).
- Histological vasculitis.
- Collagen (THE BY, scleroderma).
- Blood Pathology: Cryoglobulinemia, Polycythemia.
- Hepatitis A, B and C, HIV and syphilis infection
- Thrombophilia (search for markers during the initial assessment in patients with a history of phlebitis or miscarriage).
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- Hyperthyroidism.
- Patient treated with Hydrea (favoring the occurrence of ulcers).
- Patient participating in another study to treat the wound concerned.
- Topics minors, pregnant women, persons deprived of liberty, adults under legal protection unable to consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Caen
Caen, 14 000
Anne Dompmartin, +33 2 31 27 25 09, dompmartin-a@chu-caen.fr
Marianne Chopinaud, +33 6 85 82 29 42, mariannechopinaud@hotmail.com
About this study
The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and ulcers associated with the Hydrea ® outlet.
There is no treatment of the ulcer because conventional treatments are ineffective. The pain has subsided by analgesics III. Other treatments are not effective outside skin grafts to be repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients healed through autohemotherapy.
Read more
Ineffective treatment of this painful condition and efficiency of these cells to the damaged tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous injections of autologous fat to change the wound bed, promote healing and eliminate pain. This treatment should help to avoid long-term hospitalization (about 15 days) that can lead to physical and psychological degradation of these elderly patients.
The investigators propose an open clinical study of 10 patients with a single-center recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month recruitment and follow-up of 6 months for each patient.
The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The measure of effectiveness will also focus on the changing appearance of the wound, including the relative areas of fibrin, necrosis and budding. These efficiency measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken at each assessment time.
Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling, it would be possible to perform a multicenter study on a large number of patients to demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a shorter hospital stay, and in parallel, this approach should improve the pathophysiology of ulceration (translational research).
Read the detailed description
The objective of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and secondly, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The objective also covers the measurement of changes in the appearance of the wound, with an expected decrease of relative areas of fibrin and necrosis. The percentage of wound healing and wound area was measured at each visit, a curve will be performed for each patient to assess the speed of healing and the appearance of the wound will be notified.
- Conditions
- Skin Ulcer
- Being tested
- adipose tissue grafting
- Keywords
- necrotitis angiodermatitis, autologous fat transplantation, mesenchymal stem cells
- Medical subject headings
- Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissue graftingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| adipose tissue grafting | Experimental | Not described Receives: Procedure: adipose tissue grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of hypertensive leg ulcer by adipose tissue grafting
The objective of this study is to evaluate pain
Measured: one year
Secondary outcomes (1)
treatment of angiodermatitis necrotitis by lipofilling
Other objectives are to evaluate the tolerance, in terms of pain and side effects, and secondly, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound.
The objective also covers the measurement of changes in the appearance of the wound, with an expected decrease of relative areas of fibrin and necrosis. The percentage of wound healing and wound area was measured at each visit, a curve will be performed for each patient to assess the speed of healing and the appearance of the wound will be notified.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Dompmartin, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932021
- Sponsor's protocol ID
- 2012-A01613-40
- Acronym
- Angiolipo
- Status last verified
- Apr 2014
- First submitted
- 18 Apr 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting
- ClinicalTrials.gov ID
- NCT01932021
- Acronym / sponsor ID
- Angiolipo / 2012-A01613-40
- Conditions
- Skin Ulcer
- Keywords
- necrotitis angiodermatitis, autologous fat transplantation, mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 Aug 2013 (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.
The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and ulcers associated with the Hydrea ® outlet.
There is no treatment of the ulcer because conventional treatments are ineffective. The pain has subsided by analgesics III. Other treatments are not effective outside skin grafts to be repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients healed through autohemotherapy.
Ineffective treatment of this painful condition and efficiency of these cells to the damaged tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous injections of autologous fat to change the wound bed, promote healing and eliminate pain. This treatment should help to avoid long-term hospitalization (about 15 days) that can lead to physical and psychological degradation of these elderly patients.
The investigators propose an open clinical study of 10 patients with a single-center recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month recruitment and follow-up of 6 months for each patient.
The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The measure of effectiveness will also focus on the changing appearance of the wound, including the relative areas of fibrin, necrosis and budding. These efficiency measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken at each assessment time.
Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling, it would be possible to perform a multicenter study on a large number of patients to demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a shorter hospital stay, and in parallel, this approach should improve the pathophysiology of ulceration (translational research).
Detailed description
The objective of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and secondly, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The objective also covers the measurement of changes in the appearance of the wound, with an expected decrease of relative areas of fibrin and necrosis. The percentage of wound healing and wound area was measured at each visit, a curve will be performed for each patient to assess the speed of healing and the appearance of the wound will be notified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adipose tissue grafting | Experimental | Procedure: adipose tissue grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years with a necrotic ulcer or angiodermatitis Martorell.
- Recipient of the system of social security.
- Ulceration sudden onset peripheral Livedoid border, on superficial leg without bone or tendon exposure.
- IPS Index (systolic pressure)> 0.8 with pedal pulses.
- Wound area less than 300 cm2 surface measurement with Canvas ® software from a photograph of the wound next to which there is a calibration strip.
Key exclusion criteria (10 listed)
- Severe distal arteritis (arteritis of large arteries).
- Histological vasculitis.
- Collagen (THE BY, scleroderma).
- Blood Pathology: Cryoglobulinemia, Polycythemia.
- Hepatitis A, B and C, HIV and syphilis infection
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 |
|---|---|---|
| adipose tissue grafting | Procedure or surgery | adipose tissue grafting |
Primary outcome
Treatment of hypertensive leg ulcer by adipose tissue grafting
Time frame: one year
The objective of this study is to evaluate pain
1 secondary outcome
treatment of angiodermatitis necrotitis by lipofilling
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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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.
Anne Dompmartin, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adipose tissue grafting in people with Skin Ulcer, run by University Hospital, Caen 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 7 inclusion and 10 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 9 Apr 2014. 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.
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?
Contact Anne Dompmartin-Blanchère (+33 2 31 27 25 09, dompmartin-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of hypertensive leg ulcer by adipose tissue grafting (time frame: one year). 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 9 Apr 2014.