A Phase 2 interventional study of Irrigation Solution for wounds and Hydrogel for wound care in Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) and Chronic Wound Care, sponsored by University of Calgary. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Calgary · Phase 2, Interventional, and Health services research
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
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.
302 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 245 interventional studies indexed under Leg Ulcer.
Browse Leg Ulcer studies →University of Calgary is the lead sponsor of 699 studies on the registry; 192 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
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.
Device: Irrigation Solution for wounds
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.
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.
Device: Hydrogel for wound care
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.
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.
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.
Participant Recruitment Rate
Recruitment rate reported as the number of participants enrolled per site per month
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of treatment at 5 weeks
Wound Imaging Documentation
Proportion of participants who received scheduled wound imaging
Time frame: 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
Time frame: week 1 to week 5
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Feb 2028, 13 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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