Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease (COMPAD2)

• ClinicalTrials.gov Identifier: NCT04829812
• Recruitment Status: Completed
• First Posted: April 2, 2021
• Last Update Posted: January 12, 2022
• Sponsor: University Hospital, Montpellier
• Collaborator: Société Française de Médecine Vasculaire (SFMV)
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

Brief 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

Condition or disease
Peripheral Arterial Disease; Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

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

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey
• Actual Study Start Date: March 15, 2021
• Actual Primary Completion Date: December 1, 2021
• Actual Study Completion Date: December 21, 2021

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Efficacy and tolerance of this treatment [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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.

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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;
• 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 ...).

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Société Française de Médecine Vasculaire (SFMV)

Investigators

• Study Director: Monira NOU, PHD; University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04829812
• Other Study ID Numbers: RECHMPL21_0162
• First Posted: April 2, 2021
• Last Update Posted: January 12, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

compression system necessary; ankle brachial index; brachial index

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Foot Ulcer; Leg Ulcer; Wounds and Injuries; Foot Diseases; Skin Diseases; Skin Ulcer; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases