The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

NCT05666570 | Withdrawn FDA Device

• 1 other identifier: WC-22-432
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer

Keywords

negative pressure wound therapy; ulcer

Outcome Measures

Primary Outcomes (1)

• The reduction in wound size of the target wound between baseline and end of study

  Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day)

  14 days

Secondary Outcomes (3)

• Wound Healing Status

  14 days

• Assessment of Skin

  14 Days

• Rate of Device Related Adverse Events

  14 days

Study Arms (1)

Avelle NPWT

Avelle Negative Pressure Wound Therapy administrated as indicated by IFU

Device: Avelle NPWT

Interventions

Avelle NPWT DEVICE

Wound Management Therapy

Avelle NPWT

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

The population will be recruited from the Investigators available population in the anticipated geographies of Colombia and Australia.

You may qualify if:

• Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcer
• Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks
• qualifying wound which is amenable to NPWT
• Reliable and available for follow-up
• Low to moderate exudate
• Able to tolerate negative pressure
• \>18 years old at the time of consent
• Able and willing to provide informed consent

You may not qualify if:

• Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System
• Necrotic wounds or wounds with eschar present
• Wound is too small or too large based on wound dressing (\> 1cm2 and \< 100cm2)
• Wound depth \>2cm
• Use of DuoDERM® gel /petroleum gel/ creams/oil-based products
• Active treatment for cancer or completed within the last 3 months
• Severe malnutrition in the opinion of the investigator
• Visible bone/tendon or exposed articular capsule
• Exposed blood vessels
• Clotting disorder
• Malignant wounds
• Systemic infection
• Untreated osteomyelitis
• Patients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months)
• Wounds greater than 12 months old

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Convatec Medical Care

Bogota, Cundinamarca, 11001000, Colombia

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge Ulloa

  Contracted independent health professional

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: December 28, 2022
• Study Start: May 18, 2022
• Primary Completion: November 27, 2022
• Study Completion: March 21, 2023
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CO (1)