PMCF Study of Debridement Pad

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wounds; Venous Leg Ulcer; Pressure Ulcer; Diabetic Ulcers; Arterial Leg Ulcer; Traumatic Wounds; Postoperative Wound Healing; Burns and Scalds
• Intervention / Treatment: Device: Debridement Pad

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte E Moss, PhD; Phone Number: +44 7918915377; Email: charlotte.moss@admedsol.com
• Study Contact Backup: Name: Rebecca Forder, BA (Hons); Email: rebecca.forder@admedsol.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Clínica Cres
    • Contact: Isabel Cobian; Phone Number: +34 627898900; Email: enfermeriamadrid@clinicascres.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: Debridement Pad; Study device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the Debridement Pad	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: 1. 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.	From baseline to immediately after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety by adverse events	Safety will be evaluated as incidence of device-related adverse events	From baseline to immediately after treatment
Time recorded for procedure	Time recorded for the debridement procedure	From baseline to immediately after treatment
Removal of debris	Debris/necrosis/slough absorbed/ removed by the Debridement pad.	From baseline to immediately after treatment
Pain during procedure	Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.	From baseline to immediately after treatment
Overall clinician satisfaction	Clinician satisfaction with the device (conformability, ease of use, use of both sides, softness, integrity) will be assessed using a Likert-type scale.	From baseline to immediately after treatment
Patient tolerability	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.	From baseline to immediately after treatment
Device use wet or dry	Use of the device when wet or dry (Specified, assessed using a Likert-type scale.	From baseline to immediately after treatment

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Investigators: Principal Investigator: Pablo Castan, PhD, Hospital Carlos III

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Surgical Wound; Varicose Ulcer; Burns; Pressure Ulcer
• Other Study ID Numbers: Debridement Pad 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No