Diabetic Foot UlcerSPACENCT05666570
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
An observational study of Diabetic Foot Ulcer and Venous Leg Ulcer, run by ConvaTec Inc. at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- Avelle NPWT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 18 May 2022to 21 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be recruited from the Investigators available population in the anticipated geographies of Colombia and Australia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- Avelle NPWT
- Keywords
- negative pressure wound therapy, ulcer
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelle NPWTDevice
Wound Management Therapy
| Study group | Role | What they receive |
|---|---|---|
| Avelle NPWT | Avelle Negative Pressure Wound Therapy administrated as indicated by IFU Receives: Device: Avelle NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days
Secondary outcomes (3)
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.
Measured: 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)
Measured: 14 Days
Rate of Device Related Adverse Events
Assessment of rate of device related adverse events (ADE) associated with the dressings
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start18 May 2022
- Primary completion27 Nov 2022
- Study completion21 Mar 2023
Why it stopped: More cost effective to source real world evidence data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Ulloa, Principal investigator, Contracted independent health professional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666570
- Sponsor's protocol ID
- WC-22-432
- Acronym
- SPACE
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Demonstrate the Safety and Performance of the Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
- ClinicalTrials.gov ID
- NCT05666570
- Acronym / sponsor ID
- SPACE / WC-22-432
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Keywords
- negative pressure wound therapy, ulcer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: More cost effective to source real world evidence data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelle NPWT | – | Device: Avelle NPWTAvelle Negative Pressure Wound Therapy administrated as indicated by IFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be recruited from the Investigators available population in the anticipated geographies of Colombia and Australia.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avelle NPWTWound Management Therapy | Device | Avelle NPWT |
Primary outcome
The reduction in wound size of the target wound between baseline and end of study
Time frame: 14 days
Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day)
3 secondary outcomes
Wound Healing Status
Time frame: 14 days
Assessment of Skin
Time frame: 14 Days
Rate of Device Related Adverse Events
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Ulloa principal investigator
Contracted independent health professional
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Venous Leg Ulcer, run by ConvaTec Inc. at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction in wound size of the target wound between baseline and end of study (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.