BridgeMD
Compares treatment options for Diabetic Ulcers
Official title Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
ClinicalTrials.gov ID: NCT07312513
What this study is testing
- What it's testing
- The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patient is legally capable
- Patient has signed written informed consent
- Presence of one of the following wounds
- Venous lower leg ulcer
You likely can't join if
- Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
- Pregnancy or breast feeding
- Patient is illiterate
- Participation in a treatment clinical trial within the last 14 days and during participation in this study
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of...
- severe pain or hyperesthesia in the wound area
See the full eligibility criteria
- Age ≥ 18 years
- Patient is legally capable
- Patient has signed written informed consent
- Presence of one of the following wounds
- Venous lower leg ulcer
- Arterial ulcer
- Diabetic ulcer
- Pressure ulcer
- Post-operative wound healing by secondary intention
- Traumatic wound
- Surgical wound
- Burn or scald (grade III: after surgical debridement)
- Epidermolysis Bullosa
- Wound area \>4cm2
- The entire wound area can be displayed on one photo from a distance of 25-30 cm
- Covered with at least 30% debris, necrosis, slough, fibrotic tissue
- Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
- Pregnancy or breast feeding
- Patient is illiterate
- Participation in a treatment clinical trial within the last 14 days and during participation in this study
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
- severe pain or hyperesthesia in the wound area
- history of drug or alcohol abuse
- chronic analgesic use (especially opioids) that could influence baseline pain perception
- cognitive impairment, which may affect the ability to accurately self-report pain
- Use of anaesthesia before the debridment procedure
- presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also...
The study team makes the final eligibility decision.
Where it's taking place
- Lodz, Poland
- Lublin, Poland
- Ostróda, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lodz, Poland; Lublin, Poland; Ostróda, Poland; Wroclaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.