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OpenTrials
Completed

NCT Number: NCT07255937

PMCF Study of Debridement Pad

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 participate in the study.
  • Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
  • Symptoms & signs of systemic and / or spreading wound infection (including erythema and fever).
  • Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area).
  • Subjects who in the view of the investigator might not be suitable for inclusion in the study

Treatment and study plan

Debridement Pad

Device

Study device

Primary outcomes

  1. Performance of the Debridement Pad

    Time frame: From baseline to immediately after treatment

    Performance of the Debridement Pad on Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds. Success will be determined by the following:

    • Change of wound bed condition from baseline (pre debridement) to assessment immediately after the use of the debridement pad as defined as

    a. Percentage reduction of wound coverage of visible debris/necrosis/slough from the wound bed at baseline assessment and after procedure.

Secondary outcomes

  1. Safety by adverse events

    Time frame: From baseline to immediately after treatment

    Safety will be evaluated as incidence of device-related adverse events

  2. Time recorded for procedure

    Time frame: From baseline to immediately after treatment

    Time recorded for the debridement procedure

  3. Removal of debris

    Time frame: From baseline to immediately after treatment

    Debris/necrosis/slough absorbed/ removed by the Debridement pad.

  4. Pain during procedure

    Time frame: From baseline to immediately after treatment

    Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.

  5. Overall clinician satisfaction

    Time frame: From baseline to immediately after treatment

    Clinician satisfaction with the device (conformability, ease of use, use of both sides, softness, integrity) will be assessed using a Likert-type scale.

  6. Patient tolerability

    Time frame: From baseline to immediately after treatment

    Tolerability of the patient assessed by the clinician (assessing discomfort, pressure, burning sensation, Pain, irritation of peri wound skin, swelling and redness), assessed using a Likert-type scale.

  7. Device use wet or dry

    Time frame: From baseline to immediately after treatment

    Use of the device when wet or dry (Specified, assessed using a Likert-type scale.

Sponsors and collaborators

Lead sponsor

Advanced Medical Solutions Ltd.

Industry

Registry information

Official study title

Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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