The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Diabetic Foot Ulcer Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05666570
• Other study ID #: WC-22-432
• Status: Terminated
• Start date: May 18, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: March 2023
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: March 21, 2023
• Est. primary completion date: November 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Avelle NPWT
wound management therapy

Locations

Country	Name	City	State
Colombia	Convatec Medical Care	Bogota	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Rate of Device Related Adverse Events	Assessment of rate of device related adverse events (ADE) associated with the dressings	14 days