Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

NCT ID: NCT04829812

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-12-21

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

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility 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 ...).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française de Médecine Vasculaire (SFMV)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monira NOU, PHD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL21_0162

Identifier Type: -

Identifier Source: org_study_id