Actively Recruiting
PMCF Study of Debridement Pad
Led by Advanced Medical Solutions Ltd. · Updated on 2025-12-01
184
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PMCF Study of Debridement Pad
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or above
- Patients who can understand and provide informed consent
- Have one or more of the following wounds: diabetic ulcers, arterial and venous leg ulcers, pressure ulcers, postoperative wounds healing by secondary intention, traumatic or surgical wounds, burns and scalds
- Wounds requiring debridement due to slough debris, fibrous tissue, hyperkeratotic debris, or dried exudate on peri-wound skin
- Wounds with both serous crusts and healthy tissue
- At least 30% of the wound covered by debris, necrosis, or slough
- Wound size greater than 4 cm2
You will not qualify if you...
- Known non-compliance with medical treatment
- Known sensitivity to device components such as polyester
- Significant or unstable medical or psychiatric condition affecting study participation
- Currently enrolled in another clinical study or completed one less than 30 days before enrollment
- Symptoms or signs of systemic or spreading wound infection, including erythema and fever
- Severe pain rated 7 or higher on a 0-10 scale or hyperaesthesia in the wound area
- Investigator judgment of unsuitability for study inclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clínica Cres
Madrid, Spain
Actively Recruiting
Research Team
C
Charlotte E Moss, PhD
CONTACT
R
Rebecca Forder, BA (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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