Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

NCT04159844 | Unknown

• 1 other identifier: F-19-06-BD001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• SSI(Static Stiffness Index) ≥ 10 mmHg

  % of subject with a SSI≥ 10 mmHg

  Hour 48 after the application

Secondary Outcomes (3)

• SSI (Static Stiffness Index)

  From Hour 0 (Baseline) to Hour 72 (end of study) after application

• Interface pressure under the bandage

  From Hour 0 (Baseline) to Hour 72 after application

• Slippage of the bandage in cm

  From Hour 0 (Baseline) to Hour 72 (end of study) after application

Study Arms (3)

Short stretch bandage

ACTIVE COMPARATOR

Application with 50% overlap in combinaison with wading

Device: URGOBD001

Multi componant bandage

ACTIVE COMPARATOR

Application with 50% overlap

Device: URGOBD001

Short stretch bandage bis

ACTIVE COMPARATOR

Application with 50% overlap in combinaison with wading

Device: URGOBD001 associated with wading

Interventions

URGOBD001 DEVICE

Application with 50% overlapping

Multi componant bandage; Short stretch bandage

URGOBD001 associated with wading DEVICE

Application with 50% overlapping in association with wading

Short stretch bandage bis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a body mass index of less than 30 (BMI = kg / m²),
• Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
• Subject presenting a venous doppler of the lower limbs without detectable anomaly
• Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
• Subject accepting to wear a compressive system on both legs for a period of three days.

You may not qualify if:

• Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
• Subject with type I or II diabetes
• Subject with lipoedema and / or dismorphic leg
• Subject presenting ankle ankylosis

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

Intertek France Clinical studies

Paris, 75013, France

RECRUITING

Study Officials

• Benigni JP, MD

  Intertek France clinical studies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Batot Géraldine, PhD

CONTACT

+33 3 80 44 28 46; g.batot@fr.urgo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 separate sets : * URGOBD001 SSI compared with the SSI of a short stretch bandage * URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage * URGOBD001 SSI compared with the SSI of a multi component bandage.

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 12, 2019
• Study Start: September 3, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-10

Locations

FR (1)