Diabetic UlcersNCT07255937
PMCF Study of Debridement Pad
A study testing Debridement Pad in people with Diabetic Ulcers and Venous Leg Ulcer, run by Advanced Medical Solutions Ltd. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer
- What is being tested?
- Debridement Pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer, Postoperative Wound Healing, Traumatic Wounds
- Being tested
- Debridement Pad
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer, Surgical Wound, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement PadDevice
Study device
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Debridement Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Change of wound bed condition from baseline (pre debridement) to assessment immediately after the use of the debridement pad as defined as
- Percentage reduction of wound coverage of visible debris/necrosis/slough from the wound bed at baseline assessment and after procedure.
Measured: From baseline to immediately after treatment
Secondary outcomes (7)
Safety by adverse events
Safety will be evaluated as incidence of device-related adverse events
Measured: From baseline to immediately after treatment
Time recorded for procedure
Time recorded for the debridement procedure
Measured: From baseline to immediately after treatment
Removal of debris
Debris/necrosis/slough absorbed/ removed by the Debridement pad.
Measured: From baseline to immediately after treatment
Pain during procedure
Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start20 Nov 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Castan, PhD, Principal investigator, Hospital Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255937
- Sponsor's protocol ID
- Debridement Pad 001
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds
- ClinicalTrials.gov ID
- NCT07255937
- Acronym / sponsor ID
- Debridement Pad 001
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer, Postoperative Wound Healing, Traumatic Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Debridement Pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement PadStudy device | Device | Intervention |
Primary outcome
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: 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.
7 secondary outcomes
Safety by adverse events
Time frame: From baseline to immediately after treatment
Time recorded for procedure
Time frame: From baseline to immediately after treatment
Removal of debris
Time frame: From baseline to immediately after treatment
Pain during procedure
Time frame: From baseline to immediately after treatment
Overall clinician satisfaction
Time frame: From baseline to immediately after treatment
Patient tolerability
Time frame: From baseline to immediately after treatment
Device use wet or dry
Time frame: From baseline to immediately after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Castan, PhD principal investigator
Hospital Carlos III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement Pad in people with Diabetic Ulcers and Venous Leg Ulcer, run by Advanced Medical Solutions Ltd. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the Debridement Pad (time frame: From baseline to immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.