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A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemical Debridement | Active Comparator | 1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial |
|
| Sharp debridement | Active Comparator | In the control arm wound debridement by curettage will be performed at initiation visit and after 2 weeks when clinician deems this necessary, conform standard of care protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemical Debridement | Device | The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound surface | Change in wound surface area (cm^2) | 12 weeks |
| Wound Debris | Change in the percentage of the wound bed covered with slough | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity) | 12 weeks |
| wound condition | Condition of the wound bed by percentage of granulation tissue, percentage covered in slough, exudate; Measured via visual assessment totalling up to 100% (e.g. 30% granulation, 25% slough, 25% necrosis, 20% exudate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pioneer wound healing and lymphedema centres | Eastbourne | United Kingdom |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Curettage debridement | Device | The use of a currette will clean the wound bed. Debridement by mechanically removing the necrotic tissue and biofilm. This is performed confrom the standard of care standards. |
|
| 12 weeks |
| Quality of Life | Health-related quality of life assessed using WoundQOL (an established validated questionair production a single number between 0-1 with 1 being the optimal quality of life) | 12 weeks |
| Patient Comfort in treatment process | Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined) | 12 weeks |
| Device Safety | Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest | 12 weeks |
| Treatment Comfort in performance and acceptance | Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted. | 12 weeks |
| wound condition | Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile)) | 12 weeks |
| wound condition | Maloudour (yes, no); | 12 weeks |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |