| NCT ID | NCT07255937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Advanced Medical Solutions Ltd. |
| Condition | Diabetic Ulcers |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-07-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.
Eligibility Criteria
Inclusion Criteria: * Males or females aged 18 years or above. * Patients who can understand and give informed consent to take part in the study. * Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds * Wounds that require debridement due to the presence of slough debris/fibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin. * Wounds with both serous crusts and healthy tissue. * Minimum of 30% of the wound covered by debris, necrosis or slough. * Wound Size \> 4cm2 Exclusion Criteria: * Patients who are known to be non-compliant with medical treatment * Patients who are known to be sensitive to any of the device components such as polyester. * Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participat