Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)Phase 2COMBAT-HNCT07872930
Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds
A Phase 2 study testing Irrigation Solution for wounds and Hydrogel for wound care in people with Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) and Chronic Wound Care, run by University of Calgary.
Trial summary
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds. as measured by recruitment rate, retention, adherence to the assigned treatment schedule, and completeness of outcome data, in each of Study A (CAWL versus standard of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
- What is being tested?
- Irrigation Solution for wounds and Hydrogel for wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older at time of enrollment.
- Wound located below the knee.
- Wound surface area greater than or equal to 2 cm² and less than or equal to 50 cm² at screening.
- Wound present for at least 4 weeks prior to screening.
- Chronic wound status: failure to achieve greater than 50% wound closure after a minimum four-week lead-in period of standard of care treatment.
- Patient deemed competent to provide informed consent and able to comply with study procedures.
- No prior treatment with ComBatic™ products.
Who cannot join
- Ischaemic wounds with inadequate blood perfusion as assessed by the investigator.
- Underlying osteomyelitis.
- Active participation in another interventional clinical study.
- Any condition that, in the investigator's judgment, would place the patient at undue risk or confound study results.
- Patients identified as unlikely to comply with study procedures or required follow-up visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds: A Multi-Center, Prospective, Open-Label, Randomized Controlled Trial
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds. as measured by recruitment rate, retention, adherence to the assigned treatment schedule, and completeness of outcome data, in each of Study A (CAWL versus standard of care) and Study B (CAWH versus standard of care). The main outcomes it aims to answer are
- assessing the impact of treatment on patient-reported health-related quality of life, as measured by the global score and subscores of the validated Wound-QoL questionnaire, from baseline to end of study.
- conduct an exploratory within-trial economic evaluation by estimating healthcare resource use, associated costs, and quality-adjusted life years (QALYs) derived from the EQ-5D-5L in the intervention and usual care groups over the study period.
- evaluate the safety and tolerability of the investigational products including the incidence, nature, and severity of treatment-emergent adverse events and adverse device reactions.
- generate preliminary estimates of clinical effect in each of Study A and Study B, including change in wound surface area from baseline to end of study, change in wound appearance characteristics, and the proportion of participants achieving greater than or equal to 50% reduction in wound surface area Researchers will compare Study A (CAWL) to the control which is the site's routine wound cleansing or irrigation product, selected by the treating clinician as clinically indicated for the wound presentation. This may include an antimicrobial or antiseptic product (e.g., a silver, PHMB, iodine, or honey-based formulation) where clinically appropriate, or a non-antimicrobial solution such as normal saline where it is not. Researchers will compare Study B (CAWH) to the control which is the standard-of-care comparator is the site's routine moisture-donating dressing, selected by the treating clinician as clinically indicated. This may include a dressing with its own antimicrobial barrier claim where clinically appropriate, or a moisture-donation-only dressing where it is not.
Participants will in Study A, be given Combatic Lavage (CAWL) as the wound cleansing product. Participants will in Study B, be given Combatic Hydrogel (CAWH) as the wound moisture balancing product.
- Being tested
- Irrigation Solution for wounds, Hydrogel for wound care
- Medical subject headings
- Leg Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation Solution for woundsDevice
This wound care product is a next-generation, non-antibiotic antimicrobial wound cleansing and irrigation solution designed for rapid infection control, biofilm disruption, and wound bed preparation, composed of medical/food grade all-natural ingredients with a natural preservative system.
Hydrogel for wound careDevice
The hydrogel wound-care device is a next-generation, non-antibiotic wound gel developed to rapidly control infection and support accelerated wound healing while remaining safe for repeated and long-term use. It is designed to support natural wound healing and reduce inflammation and infection burden in complex wounds by providing an antimicrobial barrier and maintaining a moist wound environment.
| Study group | Role | What they receive |
|---|---|---|
| ComBatic™ Antimicrobial Wound Lavage (CAWL): Wound Cleansing | Experimental | CAWL is indicated for the cleansing and irrigation of acute and chronic wounds, and its indication is not restricted by wound type, etiology, infection status, or moisture level. This arm enrolls participants whose wounds show signs of active infection or suspected biofilm burden. This is an enrichment strategy adopted for the purposes of this pilot, selecting participants with an elevated cleansing and debridement requirement in whom any difference relative to standard of care cleansing is most likely to be observable. Receives: Device: Irrigation Solution for wounds |
| Standard of Care: Wound Cleansing | No intervention | The standard-of-care comparator is the site's routine wound cleansing or irrigation product, selected by the treating clinician as clinically indicated for the wound presentation. This may include an antimicrobial or antiseptic product (e.g., a silver, PHMB, iodine, or honey-based formulation) where clinically appropriate, or a non-antimicrobial solution such as normal saline where it is not. This arm enrolls participants whose wounds require cleansing and irrigation; enriched for signs of active infection or suspected biofilm burden. |
| ComBatic™ Antimicrobial Wound Hydrogel (CAWH): Wound Moisture Dressing | Experimental | CAWH is indicated as a wound dressing that provides an antimicrobial barrier and maintains a moist wound environment. This arm enrolls participants with dry or semi-dry wounds with or without active infection/biofilm requiring moisture balance, as these are the wounds in which the moisture-maintaining function of the product is indicated. Receives: Device: Hydrogel for wound care |
| Standard of Care: Wound Moisture Dressing | No intervention | The standard-of-care comparator is the site's routine moisture-donating dressing, selected by the treating clinician as clinically indicated. This may include a dressing with its own antimicrobial barrier claim where clinically appropriate, or a moisture-donation-only dressing where it is not. This arm enrolls participants with dry or semi-dry wounds requiring moisture balance, with or without active infection or suspected biofilm burden. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
Recruitment rate reported as the number of participants enrolled per site per month
Measured: From enrollment to the end of treatment at 5 weeks.
Participant Retention Rate
Retention rate reported as the proportion of randomized participants completing the week 5 end-of-study visit across all sites.
Measured: From enrollment to the end of treatment at 5 weeks
Treatment Adherence Documentation
Treatment adherence reported as the proportion of scheduled treatment applications completed as recorded on the Diary Card and Case Report Forms at the end of the 5 week study
Measured: From enrollment to the end of treatment at 5 weeks
Wound Imaging Documentation
Proportion of participants who received scheduled wound imaging
Measured: week 1, week 2, and week 5
Quality of Life Documentation
Proportion of participants who completed the quality of life assessments (Wound QoL and EQ-5D-5L) during each week of the 5-week study
Measured: week 1 to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Alberta, MHCombiotic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872930
- Sponsor's protocol ID
- REB26-0960
- Other IDs
- 10050913
- Acronym
- COMBAT-H
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds: A Multi-Center, Prospective, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07872930
- Acronym / sponsor ID
- COMBAT-H / REB26-0960
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Genome Alberta, MHCombiotic
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Oct 2026 (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 goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds. as measured by recruitment rate, retention, adherence to the assigned treatment schedule, and completeness of outcome data, in each of Study A (CAWL versus standard of care) and Study B (CAWH versus standard of care). The main outcomes it aims to answer are
- assessing the impact of treatment on patient-reported health-related quality of life, as measured by the global score and subscores of the validated Wound-QoL questionnaire, from baseline to end of study.
- conduct an exploratory within-trial economic evaluation by estimating healthcare resource use, associated costs, and quality-adjusted life years (QALYs) derived from the EQ-5D-5L in the intervention and usual care groups over the study period.
- evaluate the safety and tolerability of the investigational products including the incidence, nature, and severity of treatment-emergent adverse events and adverse device reactions.
- generate preliminary estimates of clinical effect in each of Study A and Study B, including change in wound surface area from baseline to end of study, change in wound appearance characteristics, and the proportion of participants achieving greater than or equal to 50% reduction in wound surface area Researchers will compare Study A (CAWL) to the control which is the site's routine wound cleansing or irrigation product, selected by the treating clinician as clinically indicated for the wound presentation. This may include an antimicrobial or antiseptic product (e.g., a silver, PHMB, iodine, or honey-based formulation) where clinically appropriate, or a non-antimicrobial solution such as normal saline where it is not. Researchers will compare Study B (CAWH) to the control which is the standard-of-care comparator is the site's routine moisture-donating dressing, selected by the treating clinician as clinically indicated. This may include a dressing with its own antimicrobial barrier claim where clinically appropriate, or a moisture-donation-only dressing where it is not.
Participants will in Study A, be given Combatic Lavage (CAWL) as the wound cleansing product. Participants will in Study B, be given Combatic Hydrogel (CAWH) as the wound moisture balancing product.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ComBatic™ Antimicrobial Wound Lavage (CAWL): Wound Cleansing | Experimental | Device: Irrigation Solution for woundsCAWL is indicated for the cleansing and irrigation of acute and chronic wounds, and its indication is not restricted by wound type, etiology, infection status, or moisture level. This arm enrolls participants whose wounds show signs of active infection or suspected biofilm burden. This is an enrichment strategy adopted for the purposes of this pilot, selecting participants with an elevated cleansing and debridement requirement in whom any difference relative to standard of care cleansing is most likely to be observable. |
| Standard of Care: Wound Cleansing | No intervention | –The standard-of-care comparator is the site's routine wound cleansing or irrigation product, selected by the treating clinician as clinically indicated for the wound presentation. This may include an antimicrobial or antiseptic product (e.g., a silver, PHMB, iodine, or honey-based formulation) where clinically appropriate, or a non-antimicrobial solution such as normal saline where it is not. This arm enrolls participants whose wounds require cleansing and irrigation; enriched for signs of active infection or suspected biofilm burden. |
| ComBatic™ Antimicrobial Wound Hydrogel (CAWH): Wound Moisture Dressing | Experimental | Device: Hydrogel for wound careCAWH is indicated as a wound dressing that provides an antimicrobial barrier and maintains a moist wound environment. This arm enrolls participants with dry or semi-dry wounds with or without active infection/biofilm requiring moisture balance, as these are the wounds in which the moisture-maintaining function of the product is indicated. |
| Standard of Care: Wound Moisture Dressing | No intervention | –The standard-of-care comparator is the site's routine moisture-donating dressing, selected by the treating clinician as clinically indicated. This may include a dressing with its own antimicrobial barrier claim where clinically appropriate, or a moisture-donation-only dressing where it is not. This arm enrolls participants with dry or semi-dry wounds requiring moisture balance, with or without active infection or suspected biofilm burden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older at time of enrollment.
- Wound located below the knee.
- Wound surface area greater than or equal to 2 cm² and less than or equal to 50 cm² at screening.
- Wound present for at least 4 weeks prior to screening.
- Chronic wound status: failure to achieve greater than 50% wound closure after a minimum four-week lead-in period of standard of care treatment.
Key exclusion criteria (5 listed)
- Ischaemic wounds with inadequate blood perfusion as assessed by the investigator.
- Underlying osteomyelitis.
- Active participation in another interventional clinical study.
- Any condition that, in the investigator's judgment, would place the patient at undue risk or confound study results.
- Patients identified as unlikely to comply with study procedures or required follow-up visits
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 |
|---|---|---|
| Irrigation Solution for woundsThis wound care product is a next-generation, non-antibiotic antimicrobial wound cleansing and irrigation solution designed for rapid infection control, biofilm disruption, and wound bed preparation, composed of medical/food grade all-natural ingredients with a natural preservative system. | Device | ComBatic™ Antimicrobial Wound Lavage (CAWL): Wound Cleansing |
| Hydrogel for wound careThe hydrogel wound-care device is a next-generation, non-antibiotic wound gel developed to rapidly control infection and support accelerated wound healing while remaining safe for repeated and long-term use. It is designed to support natural wound healing and reduce inflammation and infection burden in complex wounds by providing an antimicrobial barrier and maintaining a moist wound environment. | Device | ComBatic™ Antimicrobial Wound Hydrogel (CAWH): Wound Moisture Dressing |
Primary outcome
Participant Recruitment Rate
Time frame: From enrollment to the end of treatment at 5 weeks.
Recruitment rate reported as the number of participants enrolled per site per month
Participant Retention Rate
Time frame: From enrollment to the end of treatment at 5 weeks
Retention rate reported as the proportion of randomized participants completing the week 5 end-of-study visit across all sites.
Treatment Adherence Documentation
Time frame: From enrollment to the end of treatment at 5 weeks
Treatment adherence reported as the proportion of scheduled treatment applications completed as recorded on the Diary Card and Case Report Forms at the end of the 5 week study
Wound Imaging Documentation
Time frame: week 1, week 2, and week 5
Proportion of participants who received scheduled wound imaging
Quality of Life Documentation
Time frame: week 1 to week 5
Proportion of participants who completed the quality of life assessments (Wound QoL and EQ-5D-5L) during each week of the 5-week study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Related trials for Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Recruiting
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
Diabetic Foot Ulcer
Recruiting
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
RecruitingObservational study
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
RecruitingPhase 2
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Recruiting
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irrigation Solution for wounds and Hydrogel for wound care in people with Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) and Chronic Wound Care, run by University of Calgary.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Adams (4038990464, vanessa.pederson@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: From enrollment to the end of treatment at 5 weeks.). The study lists 5 primary outcomes in all. 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 14 Oct 2026.