Skip to main content
OpenTrials
Completed

NCT Number: NCT04829812

Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...).

Treatment and study plan

Primary outcomes

  1. Description of the practice of vascular specialist in the management of leg ulcers requiring medical compression

    Time frame: 1 day (inclusion visit)

    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Société Française de Médecine Vasculaire (SFMV)

Registry information

Official study title

Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey

Acronym: COMPAD2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2021
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.