Venous Leg UlcerASOLO-CWNCT04753294
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
A study testing Avance Solo NPWT System and Avance Solo Adapt NPWT System in people with Venous Leg Ulcer and Pressure Ulcer, run by Molnlycke Health Care AB at 13 sites in 7 countries.
Trial summary
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Avance Solo NPWT System and Avance Solo Adapt NPWT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 14 Jun 2021to 21 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- Male or female ≥ 18 years.
- Signed written informed consent.
- Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
- Subjects that will be capable and willing to comply with protocol instructions
Who cannot join
- Known malignancy in the wound or margins of the wound
- Untreated and previously confirmed osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
- Exposed nerves, arteries, veins or organs
- Exposed anastomotic site
Show all 9Show fewer
- Known allergy/hypersensitivity to the dressing or its components.
- Known pregnancy or planning to become pregnant or lactation at time of study participation.
- Participation in another investigative drug or device trial currently or within the last 30 days Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Germany3 sites
Franziskus-Krankenhaus Berlin
Berlin, 10787
Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin
Berlin, 12200
Klinikum der Ruhr-Universität Bochum
Bochum, 44791
Portugal3 sites
Santa casa da Misericórdia de Aveiro
Aveiro
Unidade de Cuidados Continuados António Francisco Guimarães
Guimarães
Trofa Saúde Hospital Central Hospital da Trofa
Touguinho
Belgium2 sites
Diensthoofd wondkliniek, UZ Gent
Ghent, 9000
AZ Delta
Roeselare, 8800
Italy2 sites
Ospedale San Raffaele S.r.I.
Milan, 20132
A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
Torino, 10126
About this study
Official title: A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.
Read the detailed description
This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation
A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:
- Deteriorated
- No change
- Improved
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Being tested
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance Solo NPWT SystemDevice
Wound treatment with Avance Solo NPWT System for up to 28 days.
Avance Solo Adapt NPWT SystemDevice
Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Avance Solo NPWT System | Experimental | Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers. Receives: Device: Avance Solo NPWT System |
| Avance Solo Adapt NPWT System | Experimental | Treatment with negative pressure wound therapy for Pressure ulcers. Receives: Device: Avance Solo Adapt NPWT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound progress
Wound progress compared to last visit and assessed as:
- Deteriorated
- No change
- Improved
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary outcomes (21)
Wound progress
Wound progress compared between baseline and final visit and assessed as:
- Deteriorated
- No change
- Improved
Measured: 28 days
Absolute change in wound area
Absolute change in wound area from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absolute change in wound volume
Absolute change in wound volume from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound area
Percentage change in wound area from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound volume
Percentage change in wound volume from baseline to all follow-up visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate amount
Change in exudate amount using a category scoring system from baseline to all follow-up visits.
Amount: none, low, moderate, or high)
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate nature
Change in exudate nature using a category scoring system from baseline to all follow-up visits.
Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate odor
Change in exudate odor using a category scoring system from baseline to all follow-up visits.
Odor: no odor, slight, moderate, strong, and very strong
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Peri-wound
Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions:
- Normal
- Erythematous
- Oedematous
- Eczematous
- Excoriated
- Macerated
- Indurated
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed
Pain assessment
Subject evaluation of pain at Avance Solo dressing or Avance Solo Adapt Film removal using Numeric Rating Scale (NRS) at each follow-up visit.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Trauma
Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing, fixation strips or Avance Solo Adapt Film at all follow-up visits.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessed using Numeric Rating Scale (NRS)
Impact of everyday life by the systems will be captured through a NRS scale where the subject grade how much the treatment has affected the subject's daily life. 0 is equal to no influence and 10 to considerable influence on everyday life or unbearable.
If replying >0, the subject will state the presence or absence of the following causes:
- Leakage of dressing
- Impaired mobility
- Difficulties in getting dressed
- Pain
- Odor
Measured: 28 days
Alarms
Subject evaluation of the system properties (number of sounding alarms) assessed with a given scale at all follow-up visits
- 0
- 1-5
- 6-10
- 11-15
- 16-20
- More than 20
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Compliance
Evaluate the compliance to the provided therapy by average number of hours per 24h that the system has not provided treatment since last visit.
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ability to absorb and/or transport exudate via clinical judgement
Evaluation of the Systems ability to absorb and/or transport exudate assessed using a rating scale by the clinician/designee:
- Very Poor
- Poor
- Good
- Very Good
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ease of application
Clinician evaluation of ease of application and removal of Avance®Solo or Avance®Solo Adapt using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.
Measured: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Global satisfaction
Evaluate the investigator and subject global satisfaction of the systems in regards to:
- Very dissatisfied
- Dissatisfied
- Neither satisfied or dissatisfied
- Satisfied
- Very satisfied
Measured: 28 days
Product consumption
Product consumption of the utilized products for the system's, from baseline and final visit using the Avance Solo or Avance Solo Adapt NPWT System
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time
Evaluate Avance®Solo or Avance®Solo Adapt wear time in days from baseline to all follow-up visits including potential extra visits
Measured: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start14 Jun 2021
- Primary completion15 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Leg 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Hilde Beele, Prof. Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753294
- Sponsor's protocol ID
- PD-598654
- Acronym
- ASOLO-CW
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beele H, Gomes CF, Vieira N, Castro J, Alves P. Dynamic management of pressure injuries using a portable canister-based single-use negative pressure wound therapy device. J Wound Care. 2026 Feb 2;35(2):125-136. doi: 10.12968/jowc.2025.0541. Epub 2026 Feb 6.
PubMed 41649921
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds
- ClinicalTrials.gov ID
- NCT04753294
- Acronym / sponsor ID
- ASOLO-CW / PD-598654
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Keywords
- Negative Pressure Wound Therapy, Post Market Clinical Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 15 Feb 2021 (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.
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.
Detailed description
This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation
A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:
- Deteriorated
- No change
- Improved
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.
| Arm | Type | Receives |
|---|---|---|
| Avance Solo NPWT System | Experimental | Device: Avance Solo NPWT SystemTreatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers. |
| Avance Solo Adapt NPWT System | Experimental | Device: Avance Solo Adapt NPWT SystemTreatment with negative pressure wound therapy for Pressure ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years.
- Signed written informed consent.
- Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
- Subjects that will be capable and willing to comply with protocol instructions
Key exclusion criteria (9 listed)
- Known malignancy in the wound or margins of the wound
- Untreated and previously confirmed osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
- Exposed nerves, arteries, veins or organs
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 |
|---|---|---|
| Avance Solo NPWT SystemWound treatment with Avance Solo NPWT System for up to 28 days. | Device | Avance Solo NPWT System |
| Avance Solo Adapt NPWT SystemWound treatment with Avance Solo Adapt NPWT System for up to 28 days. | Device | Avance Solo Adapt NPWT System |
Primary outcome
Change in wound progress
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved
21 secondary outcomes
Wound progress
Time frame: 28 days
Absolute change in wound area
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absolute change in wound volume
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound area
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound volume
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate amount
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate nature
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate odor
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Peri-wound
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed
Pain assessment
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Trauma
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessed using Numeric Rating Scale (NRS)
Time frame: 28 days
Alarms
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Compliance
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ability to absorb and/or transport exudate via clinical judgement
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ease of application
Time frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Global satisfaction
Time frame: 28 days
Product consumption
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 41649921Beele H, Gomes CF, Vieira N, Castro J, Alves P. Dynamic management of pressure injuries using a portable canister-based single-use negative pressure wound therapy device. J Wound Care. 2026 Feb 2;35(2):125-136. doi: 10.12968/jowc.2025.0541. Epub 2026 Feb 6.
- Individual participant dataSharing planned: No
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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.
Hilde Beele, Prof. Dr. principal investigator
University Hospital, Ghent
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance Solo NPWT System and Avance Solo Adapt NPWT System in people with Venous Leg Ulcer and Pressure Ulcer, run by Molnlycke Health Care AB at 13 sites in 7 countries.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Portugal, Belgium, Italy, Denmark and 2 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in wound progress (time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753294, which also lists 1 linked publication.
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 Sep 2023.