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Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)

ConditionLeg Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires URGO

About this trial

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient (≥ 18 years old), having given free, informed and written consent

Patient affiliated to a social security scheme

Patient agreeing to wear the study compression system daily

Patient with an ankle circumference between 18 and 25 cm

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

    Device

    Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

  • Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification

    Device

    Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: light compression systemExperimental treatment 2 interventions
Group B: tubular bandagePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complete closure of the Venous Leg Ulcer (VLU)

Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)

Time frame
16-week treament period

Secondary outcomes

1

Time to complete closure of the Venous Leg Ulcer (VLU)

Description: Time to complete closure of the Mixed Leg Ulcer (MLU) is defined as the time from inclusion to the date of complete closure

Time frame
16-week treament period
2

Safety analysis

Nature and number of adverse event related to the use of the studied light compression system and tubular bandage (serious/ non-serious and emergent)

Time frame
16-week treament period

Other outcomes

Sponsors and contacts

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Laboratoires URGO

Lead sponsor

Source ClinicalTrials.gov
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