The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds (SPACE)

A Study to Demonstrate the Safety and Performance of the Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer
• Intervention / Treatment: Device: Avelle NPWT

Detailed Description

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use.

Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.

• Study Type: Observational

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 11001000
      • Convatec Medical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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
• 1 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

Exclusion Criteria:

• 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
• Previous failed NPWT within last 6 weeks on the qualifying wound
• Active Pregnancy
• Chronic Kidney Disease score of 5

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Avelle NPWT; Avelle Negative Pressure Wound Therapy administrated as indicated by IFU	Device: Avelle NPWT; Wound Management Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Status	Assessment of wound progression between baseline and 14 day visit. Wounds will be assessed as healed or progressing towards healing by the investigator.	14 days
Assessment of Skin	Assessment of condition of surrounding skin and signs of infection around the wound using a standardized wound assessment tool (as captured within study database)	14 Days
Rate of Device Related Adverse Events	Assessment of rate of device related adverse events (ADE) associated with the dressings	14 days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Jorge Ulloa, Contracted independent health professional

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ulcer; negative pressure wound therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Ulcer; Varicose Ulcer; Diabetic Foot
• Other Study ID Numbers: WC-22-432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No