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Search / Trial NCT04829812

Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 31, 2021

Trial Information

Current as of June 28, 2025

Completed

Keywords

Compression System Necessary Ankle Brachial Index Brachial Index

ClinConnect Summary

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...

Gender

ALL

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 ...).

About University Hospital, Montpellier

The University Hospital of Montpellier is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its commitment to patient-centered care, the hospital collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. By integrating clinical practice with education and research, the University Hospital of Montpellier aims to enhance health outcomes and contribute to the scientific community's understanding of complex medical conditions. Its robust infrastructure and expertise make it a pivotal player in the landscape of clinical research.

Locations

Montpellier, , France

Patients applied

0 patients applied

Trial Officials

Monira NOU, PHD

Study Director

University Hospital, Montpellier

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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