Peripheral Arterial DiseaseCOMPAD2NCT04829812
Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease and Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2021to 21 Dec 2021
- Phase
- Observational
- 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
Study population: Patient presenting: - a leg ulcer: these are incidental cases of leg ulcers with or without edema but giving rise to the benefit of compressive treatment. . Foot ulcer is not included. - PAD, the diagnosis of which is retained by the investigator, based on clinical and hemodynamic criteria, the method (s) and results of which he will specify.
Who may be able to join
- Patient taken care of by a vascular specialist
- Practicing, in a hospital or not or in a healing center,
- Caring for patients with leg ulcers requiring the indication of compression treatment,
- Can include consecutive patients at each consultation over the entire duration of the study or at a pre-established rate of at least half a day per week
- Patient with a chronic leg wound (leg ulcer and foot ulcer), defined as a chronic leg wound that does not spontaneously tend to heal after 6 weeks in the case of a first episode or 2 weeks in the case of recurrenceo In principle justifying a compression treatment, o And concomitantly presenting with PAD, retained by the investigator according to clinical and hemodynamic criteria that he will describe.
Who cannot join
- Patient not giving his consent for collection of study data
- Patient with a life expectancy of less than 6 months.
- Patients for whom telephone follow-up is impossible (no contact possible with the patient, family and friends, IDE and the doctor)
- Patient presenting:
- A leg wound that is not chronic, or does not validate the ulcer criteria;
- An ulcer not located on the leg, in particular trophic disorders above the knee;
Show all 14Show fewer
- Necrotic angiodermatitis
- Systemic sclerosis
- An infected ulcer (not temporary)
- An arterial ulcer, with PAD at the critical ischemia stage (ICC 2020 consensus), ABI<0.6, systolic ankle pression <60mmHg, systolic toe pression<30mmHg, TCPO2<20mmHg, bypass of lower limbs
- Patients for whom compression is not an option, regardless of arteriopathy, especially in cases of:
- Allergy or intolerance to compression equipment
- Practical or organizational installation difficulties
- Morphotype difficult to fit (due to obesity, cachexia, trauma, dermatosis or other ...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey
Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs
Read the detailed description
The leg chronic wound is a frequent and recurrent chronic disease of the lower limb, causing an impairment in the quality of life of patients and at a significant cost to society. Medical compression is essential for the healing of a leg ulcer.
However, the leg chronic wound is often associated with peripheral arterial disease (PAD), the prevalence of which in this population varies depending on the detection method used and the stage of arterial disease. The association of a chronic wound of the lower limb with PAD can occur two problems: the indication for compression and the validity of vascular explorations to detect arterial involvement and assess its severity.
The first issue concerns the use of compression in the presence of an PAD, which is the subject of controversy. Indeed, compression can improve tissue perfusion by reducing edema, but it carries a potential risk of ischemia and worsening of the ulcer, which probably increases with the progressive stage of PAD. Thus, medical compression is sometimes contraindicated, but the PAD severity threshold setting the contraindication varies from one recommendation to another.
The second problem concerns the validity of the detection and quantification methods of the PAD. Arterial involvement is probably underestimated by the clinic alone, in these patients whose mobility is sometimes reduced or who have trophic disorders of mixed origin, and the use of additional examinations (Doppler ultrasound, ankle or toe systolic pressures, TcPO2 or other vascular explorations) is necessary. There is no specific studies in the context of chronic wound of the lower limb (leg ulcer and foot ulcer) nevertheless hemodynamic measurements remain important to guide the indication (and the contraindication) for compression and the choice of the type of compression, suitable for each patient.
It seems important to evaluate this management charge by a practice investigation, in real life. Thus, the aim of this study is an observation of the real-life survey type of vasculars specialists in France caring for patients with a chronic wound of the lower limb (leg ulcer and foot ulcer) for which compression treatment would be indicated and arterial disease of the lower limbs. This is a prospective cohort with inclusion of consecutive or pseudo-consecutive patients by vascular specialist. Patients will be followed to ulcer development and tolerance of compression during 6 months.
- Keywords
- compression system necessary, ankle brachial index, brachial index
- Medical subject headings
- Peripheral Arterial Disease, Leg Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Prospective cohort with inclusion of consecutive or pseudo-consecutive patients by vascular specialist at their place of practice. Patient follow-up to assess wound progression and compression tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the practice of vascular specialist in the management of leg ulcers requiring medical compression
- Description of the practice of vascular specialist in the management of chronic wound of lower limbs (CWOLL) requiring medical compression Methods do they use to detect and assess the severity of PAD: ( for example: ABI, TBI, USDuplex, pole test etc…) before the choice of de compression
Measured: 1 day (inclusion visit)
Secondary outcomes (1)
Efficacy and tolerance of this treatment
To prepare for future studies, markers of efficacy and tolerance of this treatment will be collected such as reduction of oedema (ankle circumference) , healing ulcer (planimetry), additional treatment (surgery, medical) and occurrence of adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start15 Mar 2021
- Primary completion1 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Médecine Vasculaire (SFMV)
- Responsible party
- Sponsor
- Investigators
- Monira NOU, PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829812
- Sponsor's protocol ID
- RECHMPL21_0162
- Acronym
- COMPAD2
- Status last verified
- Dec 2021
- First submitted
- 17 Mar 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey
- ClinicalTrials.gov ID
- NCT04829812
- Acronym / sponsor ID
- COMPAD2 / RECHMPL21_0162
- Keywords
- compression system necessary, ankle brachial index, brachial index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Société Française de Médecine Vasculaire (SFMV)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- 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.
Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs
Detailed description
The leg chronic wound is a frequent and recurrent chronic disease of the lower limb, causing an impairment in the quality of life of patients and at a significant cost to society. Medical compression is essential for the healing of a leg ulcer.
However, the leg chronic wound is often associated with peripheral arterial disease (PAD), the prevalence of which in this population varies depending on the detection method used and the stage of arterial disease. The association of a chronic wound of the lower limb with PAD can occur two problems: the indication for compression and the validity of vascular explorations to detect arterial involvement and assess its severity.
The first issue concerns the use of compression in the presence of an PAD, which is the subject of controversy. Indeed, compression can improve tissue perfusion by reducing edema, but it carries a potential risk of ischemia and worsening of the ulcer, which probably increases with the progressive stage of PAD. Thus, medical compression is sometimes contraindicated, but the PAD severity threshold setting the contraindication varies from one recommendation to another.
The second problem concerns the validity of the detection and quantification methods of the PAD. Arterial involvement is probably underestimated by the clinic alone, in these patients whose mobility is sometimes reduced or who have trophic disorders of mixed origin, and the use of additional examinations (Doppler ultrasound, ankle or toe systolic pressures, TcPO2 or other vascular explorations) is necessary. There is no specific studies in the context of chronic wound of the lower limb (leg ulcer and foot ulcer) nevertheless hemodynamic measurements remain important to guide the indication (and the contraindication) for compression and the choice of the type of compression, suitable for each patient.
It seems important to evaluate this management charge by a practice investigation, in real life. Thus, the aim of this study is an observation of the real-life survey type of vasculars specialists in France caring for patients with a chronic wound of the lower limb (leg ulcer and foot ulcer) for which compression treatment would be indicated and arterial disease of the lower limbs. This is a prospective cohort with inclusion of consecutive or pseudo-consecutive patients by vascular specialist. Patients will be followed to ulcer development and tolerance of compression during 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –Prospective cohort with inclusion of consecutive or pseudo-consecutive patients by vascular specialist at their place of practice. Patient follow-up to assess wound progression and compression tolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting: - a leg ulcer: these are incidental cases of leg ulcers with or without edema but giving rise to the benefit of compressive treatment. . Foot ulcer is not included. - PAD, the diagnosis of which is retained by the investigator, based on clinical and hemodynamic criteria, the method (s) and results of which he will specify.
Key inclusion criteria (5 listed)
- Patient taken care of by a vascular specialist
- Patient with a chronic leg wound (leg ulcer and foot ulcer), defined as a chronic leg wound that does not spontaneously tend to heal after 6 weeks in the case of a first episode or 2 weeks in the case of recurrenceo In principle justifying a compression treatment, o And concomitantly presenting with PAD, retained by the investigator according to clinical and hemodynamic criteria that he will describe.
Key exclusion criteria (14 listed)
- Patient not giving his consent for collection of study data
- Patient with a life expectancy of less than 6 months.
- Patients for whom telephone follow-up is impossible (no contact possible with the patient, family and friends, IDE and the doctor)
- Patient presenting:
- A leg wound that is not chronic, or does not validate the ulcer criteria;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the practice of vascular specialist in the management of leg ulcers requiring medical compression
Time frame: 1 day (inclusion visit)
1. Description of the practice of vascular specialist in the management of chronic wound of lower limbs (CWOLL) requiring medical compression Methods do they use to detect and assess the severity of PAD: ( for example: ABI, TBI, USDuplex, pole test etc…) before the choice of de compression
1 secondary outcome
Efficacy and tolerance of this treatment
Time frame: 6 months
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 12 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Monira NOU, PHD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), run by University Hospital, Montpellier 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 5 inclusion and 14 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 12 Jan 2022. 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?
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?
Description of the practice of vascular specialist in the management of leg ulcers requiring medical compression (time frame: 1 day (inclusion visit)). 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 12 Jan 2022.