PMCF Study of Debridement Pad

NCT07255937 | Recruiting

• 1 other identifier: Debridement Pad 001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ulcers; Venous Leg Ulcer; Arterial Leg Ulcer; Pressure Ulcer; Postoperative Wound Healing; Traumatic Wounds; Surgical Wounds; Burns and Scalds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Safety by adverse events

  From baseline to immediately after treatment

• Time recorded for procedure

  From baseline to immediately after treatment

• Removal of debris

  From baseline to immediately after treatment

• Pain during procedure

  From baseline to immediately after treatment

• Overall clinician satisfaction

  From baseline to immediately after treatment

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Debridement Pad

Interventions

Debridement Pad DEVICE

Study device

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

Study Sites (1)

Clínica Cres

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer; Surgical Wound; Burns

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Pablo Castan, PhD

  Hospital Carlos III

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte E Moss, PhD

CONTACT

+44 7918915377; charlotte.moss@admedsol.com

Rebecca Forder, BA (Hons)

CONTACT

rebecca.forder@admedsol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)