Clinical trial NCT05666570: The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
Official title: A Study to Demonstrate the Safety and Performance of the Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Keywords: negative pressure wound therapy
ulcer
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-28
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The reduction in wound size of the target wound between baseline and end of study
timeFrame: 14 days
Secondary outcomes:
measure: Wound Healing Status
timeFrame: 14 days
measure: Assessment of Skin
timeFrame: 14 Days
measure: Rate of Device Related Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Convatec Medical Care
state: Cundinamarca
Study officials:
affiliation: Contracted independent health professional
name: Jorge Ulloa
role: PRINCIPAL_INVESTIGATOR
References: