Chronic WoundsNCT06306716
A Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
An observational study of Chronic Wounds and Acute Wounds, run by Smith & Nephew, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds, Acute Wounds
- What is being tested?
- RENASYS Film with AIRLOCK Technology
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 May 2024to 31 Oct 2025
- 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: This study aims to enroll up to 42 subjects from clinical sites in the United States and Canada with appropriate wound types including: * Chronic* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) * Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause. As this is a pilot study, there are no limits to the inclusion of any particular wound type (chronic or acute) or inpatient/outpatient care at time of enrollment. Patients must be able to attend follow-up visits in clinic if they are receiving outpatient care.
Who may be able to join
- Subject has provided written informed consent.
- Subject is 18 years of age or over.
- Subject is able and willing to comply with study requirements.
- Subject is suitable to participate in the study in the opinion of the Investigator. .
- Subject has a wound(s) that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) *Chronic wound(s) in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause
- Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device
Who cannot join
- Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound
- Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study.
- Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments.
- For lower extremity wounds**, any subject with a wound on a limb with an inadequate arterial supply confirmed by one of the following within 14 days of treatment:
- Ankle Brachial Index (ABI) <0.7
- Toe Brachial Index (TBI) <0.5
Show all 18Show fewer
- Great toe pressure <40mmHg
- Abnormal triphasic or biphasic waveform patterns at the ankle **This criteria is not applicable for patients having an above, or below knee amputation.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria.
- Subject has had the target wound for greater than three months.
- Subject has a target wound that measures <3 millimeters (mm) in maximum depth.
- Subject has untreated osteomyelitis
- Subject has active, untreated soft tissue infection.
- Subject has wounds that has been managed with NPWT in the previous four (4) weeks
- Subject has participated previously in this clinical trial.
- Subject has a history of poor compliance with medical treatment.
- Pregnancy at time of enrolment.
- Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Puerto Rico1 site
Wound Care Plus Research and Education Center
San Juan, PR, 00918
About this study
Official title: A Clinical Evaluation of a New NPWT Dressing
The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.
Read the detailed description
The primary objective is to evaluate the percentage of wounds progressing to healing at the end of the treatment period. The study will also evaluate the percentage of granulation tissue, pain experienced on dressing change and safety by way of incidence and nature of device-related or procedure-related Adverse Events and Device Deficiencies.
- Conditions
- Chronic Wounds, Acute Wounds
- Being tested
- RENASYS Film with AIRLOCK Technology
- Keywords
- Negative Pressure Wound Therapy (NPWT) Dressing, RENASYS Film with AIRLOCK Technology, Chronic and acute wounds
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENASYS Film with AIRLOCK TechnologyDevice
Also called RENASYS Dressing
RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems
| Study group | Role | What they receive |
|---|---|---|
| Chronic and acute wounds | Subjects hospitalized due to chronic and acute wounds Receives: Device: RENASYS Film with AIRLOCK Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Status
Progression of wound healing will be assessed by the treating clinician and compared to the wound at treatment Day 0 (baseline) by recording on a 4-point Likert scale as:
- "Wound healed"
- "Wound progressing to healing"
- "Wound static"
- "Wound deteriorating"
Any subject responding within the 2 categories of "Wound healed" or "Wound progressing to healing" will be considered a success.
Measured: End of treatment period, up to 3 weeks
Secondary outcomes (5)
Percentage Reduction in Wound Volume from Baseline to Week 3
Percentage reduction in wound volume as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Measured: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound Area from Baseline to Week 3
Percentage reduction in wound area as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Measured: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound depth from Baseline to Week 3
Percentage reduction in wound depth as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Measured: Day 0, 1, 2, and 3 Weeks
Percentage Area of Wound Bed Covered with Granulation Tissue
The percentage of the wound bed covered with granulation tissue will be summarised using continuous summary statistics at day 0, weeks 1, 2 and 3 for each wound type and overall.
Measured: Day 0, 1, 2, and 3 Weeks
Peri-wound Pain Scores at Dressing Removal
Pain scores on removal of the dressing specifically from the peri-wound skin will be assessed using a 0-100 Visual Analog Scale (VAS) scale, with zero (0) indicating no pain and 100 indicating the worst possible pain.
Measured: Day 0, 1, 2, and 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 May 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Why it stopped: The primary reason for this early termination is insufficient enrollment, compounded by recruitment challenges and Impending Expiry of Study Product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Baboolal, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306716
- Sponsor's protocol ID
- LEO.2021.10
- Status last verified
- Sep 2025
- First submitted
- 29 Feb 2024
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a New NPWT Dressing
- ClinicalTrials.gov ID
- NCT06306716
- Acronym / sponsor ID
- LEO.2021.10
- Conditions
- Chronic Wounds, Acute Wounds
- Keywords
- Negative Pressure Wound Therapy (NPWT) Dressing, RENASYS Film with AIRLOCK Technology, Chronic and acute wounds
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The primary reason for this early termination is insufficient enrollment, compounded by recruitment challenges and Impending Expiry of Study Product
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Mar 2024 (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 purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.
Detailed description
The primary objective is to evaluate the percentage of wounds progressing to healing at the end of the treatment period. The study will also evaluate the percentage of granulation tissue, pain experienced on dressing change and safety by way of incidence and nature of device-related or procedure-related Adverse Events and Device Deficiencies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic and acute wounds | – | Device: RENASYS Film with AIRLOCK TechnologySubjects hospitalized due to chronic and acute wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to enroll up to 42 subjects from clinical sites in the United States and Canada with appropriate wound types including: * Chronic* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list) * Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause. As this is a pilot study, there are no limits to the inclusion of any particular wound type (chronic or acute) or inpatient/outpatient care at time of enrollment. Patients must be able to attend follow-up visits in clinic if they are receiving outpatient care.
Key inclusion criteria (6 listed)
- Subject has provided written informed consent.
- Subject is 18 years of age or over.
- Subject is able and willing to comply with study requirements.
- Subject is suitable to participate in the study in the opinion of the Investigator. .
- Subject has a wound(s) that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) *Chronic wound(s) in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause
Key exclusion criteria (18 listed)
- Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound
- Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study.
- Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments.
- For lower extremity wounds**, any subject with a wound on a limb with an inadequate arterial supply confirmed by one of the following within 14 days of treatment:
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria.
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 |
|---|---|---|
| RENASYS Film with AIRLOCK TechnologyAlso: RENASYS DressingRENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems | Device | Chronic and acute wounds |
Primary outcome
Wound Healing Status
Time frame: End of treatment period, up to 3 weeks
Progression of wound healing will be assessed by the treating clinician and compared to the wound at treatment Day 0 (baseline) by recording on a 4-point Likert scale as: * "Wound healed" * "Wound progressing to healing" * "Wound static" * "Wound deteriorating" Any subject responding within the 2 categories of "Wound healed" or "Wound progressing to healing" will be considered a success.
5 secondary outcomes
Percentage Reduction in Wound Volume from Baseline to Week 3
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound Area from Baseline to Week 3
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound depth from Baseline to Week 3
Time frame: Day 0, 1, 2, and 3 Weeks
Percentage Area of Wound Bed Covered with Granulation Tissue
Time frame: Day 0, 1, 2, and 3 Weeks
Peri-wound Pain Scores at Dressing Removal
Time frame: Day 0, 1, 2, and 3 Weeks
Results and safety
The study was stopped early (reason given: The primary reason for this early termination is insufficient enrollment, compounded by recruitment challenges and Impending Expiry of Study Product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Wounds
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Not yet recruiting
Utilizing RENASYS◊ DYNAFLOW Instillation Therapy System for Wound Management in Adults With Acute and Chronic Wounds
Wounds and Injuries
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
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.
Thomas Baboolal study chair
Smith & Nephew, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Wounds and Acute Wounds, run by Smith & Nephew, Inc. at 2 sites in 2 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 6 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: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Puerto Rico. 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 stopped early (reason given: The primary reason for this early termination is insufficient enrollment, compounded by recruitment challenges and Impending Expiry of Study Product). Results are not available in the source record.
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?
Wound Healing Status (time frame: End of treatment period, up to 3 weeks). 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 4 Nov 2025.