Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

NCT04613687 | Unknown

• 1 other identifier: FI-19-09-BD001
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Relative reduction in wound surface area (percent)

  Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = \[(SW6 - SD0)/SD0\] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6

  6 weeks

Secondary Outcomes (5)

• Complete ulcer closure:

  6 weeks or last assessment

• Venous oedema

  6 weeks or last assessment

• Patient quality of Life (EuroQoL 5D-5L)

  6 weeks or last assessment

• Evolution of the periwound skin

  6 weeks or last assessment

• Safety analysis

  6 weeks or last assessment

Study Arms (1)

URGOBD001

EXPERIMENTAL

Compression bandage

Device: Compression bandage

Interventions

Compression bandage DEVICE

Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

URGOBD001

Eligibility Criteria

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

You may qualify if:

• Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
• Wound in granulation phase (granulation tissue ≥50%),
• Wound at least 3 cm away from any edge of another wound,
• VLU between 2 and 20 cm2 in surface area,
• VLU duration between 1 to 24 months.

You may not qualify if:

• Patient under guardianship or protection of vulnerable adult,
• Patient with known allergy to any components of the tested compression system,
• Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
• Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
• Patient with non-controlled systemic infection by a suitable antibiotic therapy,
• Patient with a lymphedema due to lymphatic obstruction,
• Diabetic patient with advanced diagnosed microangiopathy,
• Bedridden patient, or those spending less than one hour per day on their feet,
• Wound covered partially or totally with necrotic tissue,
• Clinically infected wound,
• Wound requiring surgical treatment or for which a surgery is scheduled during the study period,
• Cancerous lesions.

Sponsors & Collaborators

• Laboratoires URGO: lead

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Senet Patricia, MD

  Vascular dermatologist, APHP, Paris, France

  PRINCIPAL INVESTIGATOR

• Dissemond Joachim, MD

  Clinic for dermatology, Essen- Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Batot Géraldine, PhD

CONTACT

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

Tacca Olivier, PhD

CONTACT

+33 3 80 44 74 22; o.tacca@fr.urgo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi centre, non-comparative study

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 3, 2020
• Study Start: October 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-10