Chronic (non-healing) ulcers of the lower leg Skin and Connective Tissue Diseases
Conditions
Interventions
Participants are randomized into one of two arms in a 1:2 ratio as follows:
Group 1: Standard of Care [comprising ActivHeal + secondary dressing + compression bandaging] (n = 10), applied three times
Sponsors
SolasCure Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 years and older at screening who are willing and able to attend and comply with all study visits and study-related activities 2. Provide a signed and dated written informed consent 3. Presence of =50% slough or devitalized tissue within the reference ulcer and suitable for debridement therapy 4. Participants with at least one defined VLU suitable for treatment that is no smaller than 2 cm2 and no larger than 50 cm2 and is confirmed as venous in origin by clinical assessments, by Ankle Brachial Pressure Index (ABPI) =0.8 and/or toe systolic BP pressure > 70mm Hg. Participants with more than one VLU on the target leg can be included, provided other ulcers are at least 1 cm away from the reference ulcer identified for treatment. Selection of the reference ulcer will be at the investigator’s discretion, provided it meets all other inclusion/exclusion criteria. 5. Confirmed, clinically diagnosed VLU (ulceration of the lower limb, with no other mechanistic explanation and which has persisted for 6 weeks or more) but which has been present for =2 years, defined by patient reporting or clinical records
Exclusion criteria
Exclusion criteria: 1. Reduction in the wound area of =40% within the 2-week screening period, when administered standard of care [moist wound healing dressing + compression bandaging] only 2. Participants who have reported poorly controlled diabetes within 3 months of the screening period 3. Participants with amputation above a trans metatarsal amputation (TMA) in the target leg 4. Reference ulcer has exposed tendons, ligaments, muscle, or bone 5. Reference ulcer [at end of screening] with high levels of exudate, which in the opinion of the investigator, would render the proposed trial management protocol unsuitable 6. Reference ulcer has an active infection at screening determined by the investigator using clinical assessment 7. Active osteomyelitis, cellulitis or gangrene in either leg 8. Participants with current active malignancy [other than basal cell carcinoma] requiring active immune or chemotherapy treatment 9. Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 4 weeks before screening 10. Prior skin graft, negative pressure therapy, ultrasound therapy, systemic or cutaneously applied growth factor, other enzymatic debriding agents (e.g. Collagenase, Nexobrid) or live maggot therapy applied to the reference ulcer within 2 weeks before screening 11. Currently enrolled or has been enrolled in the last 30 days in another investigational device or drug study 12. Known allergy or hypersensitivity to any component of the investigational product, medication or surgical dressings to be used in the study 13. Participants who lack the capacity to provide informed consent 14. Any patient which the investigator otherwise considers unsuitable for entry into the study, by reason of acute or chronic mental or physical condition that may interfere with the collection of safety and/or efficacy data 15. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency and severity of adverse events measured using standardized adverse event reporting forms over 4 weeks 2. Frequency and severity of reference wound-related local adverse events (AEs) measured at each visit using standardized forms, focusing on pain, redness, swelling, and exudate (incidence of treatment-emergent AEs and serious AEs [SAEs]) over the period of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Debridement efficacy will be measured by assessing: 1. Proportion of patients achieving “complete debridement” measured by clinical assessor upon assessment of wound at 3, 6, and 9 applications 2. Mean/median reduction in slough and eschar content measured using the percentage of wound surface area, at 1, 2, and 3 weeks (Change in surface area of devitalised tissue compared to baseline) 3. Time to achieve complete debridement measured using data recorded for each patient (in days) 4. Extent of recurrence of slough measured using data recording treatment discontinuation (Percentage of wound area) Healing potential will be measured by assessing: 5. Proportion of granulation tissue measured using the percentage of wound surface area at 1, 2, 3, and 4 weeks 6. Linear wound healing rates measured using recorded data to calculate over 1, 2, 3, and 4 weeks, recorded in mm/day 7. Mean/median surface area reduction measured using recorded data over 1, 2, 3, and 4 weeks, recorded in cm2 and as a percentage 8. Linear healing rates measured using recorded data to compare between the 2-week run-in period and the first/last 2 weeks of treatment, recorded in mm/day. 9. Mean surface area reduction measured using recorded data to compare between the 2-week run-in period and the first/last 2 weeks of treatment. (Percentage of wound surface area) 10. Change in study wound pain burden from baseline measured using a Numerical Rating Scale (NRS) measured at each visit 11. Wound QoL measured using the Forgotten Wound Score (QoL) at visit 1, 2 and 11 | — |
Countries
England, United Kingdom
Contacts
Public Contact. SolasCure Ltd.
Outcome results
None listed