Medical Compression in Patients With Chronic Wound and Peripheral Arterial Disease

NCT04829812 | Completed

• 1 other identifier: RECHMPL21_0162
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

compression system necessary; ankle brachial index; brachial index

Outcome Measures

Primary Outcomes (1)

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

  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 day (inclusion visit)

Secondary Outcomes (1)

• Efficacy and tolerance of this treatment

  6 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 ...).

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Société Française de Médecine Vasculaire (SFMV): collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Leg Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases

Study Officials

• Monira NOU, PHD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 2, 2021
• Study Start: March 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 21, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

FR (1)