BridgeMD
New treatment option for Diabetic Foot Ulcer (DFU)
Official title PAW-Hydrogel for Chronic Wound Healing
ClinicalTrials.gov ID: NCT07541196
What this study is testing
- What it's testing
- The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are: Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care?
- 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
- Adults ≥ 18 years of age.
- Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer)...
- Wound surface area between 2 cm² and 20 cm².
- For diabetic patients: HbA1c \< 9% (stable metabolic control).
- Able and willing to provide written informed consent.
You likely can't join if
- Clinical or radiological evidence of osteomyelitis (Wagner grade \> 3).
- Severe arterial insufficiency (ankle-brachial index \< 0.5).
- Use of systemic corticosteroids or immunosuppressants.
- Pregnancy or lactation.
- Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).
- Active malignancy or undergoing chemotherapy/radiotherapy.
See the full eligibility criteria
- Adults ≥ 18 years of age.
- Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration \> 3 months.
- Wound surface area between 2 cm² and 20 cm².
- For diabetic patients: HbA1c \< 9% (stable metabolic control).
- Able and willing to provide written informed consent.
- Clinical or radiological evidence of osteomyelitis (Wagner grade \> 3).
- Severe arterial insufficiency (ankle-brachial index \< 0.5).
- Use of systemic corticosteroids or immunosuppressants.
- Pregnancy or lactation.
- Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).
- Active malignancy or undergoing chemotherapy/radiotherapy.
- Participation in another treatment clinical trial within 30 days prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Ocoyoacac, State of Mexico, Mexico
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 Ocoyoacac, State of Mexico, Mexico. 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.