Actively Recruiting
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Led by Medaxis, LLC · Updated on 2024-11-21
180
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
M
Medaxis, LLC
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.
CONDITIONS
Official Title
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Current wound present for more than 4 weeks and treated for less than 1 year
- Wound size between 1.0 cm2 and 25 cm2 at first study visit
- Willing and able to participate in weekly study visits
- Signed informed consent form prior to study procedures
- For diabetic foot ulcers: Wagner Grade 1 or 2 without abscess or osteomyelitis, largest ulcer evaluated, other ulcers on same foot must be >2 cm from index ulcer, offloaded for at least 14 days prior to randomization, adequate circulation documented by specified vascular assessments
- For venous leg ulcers: meet CEAP VLU classification except exclusions, largest ulcer evaluated, other ulcers on same leg must be >2 cm from index ulcer, adequate circulation documented by specified vascular assessments
- For surgical dehisced wounds: meet Sandy Grading System except exclusions
- For traumatic wounds: meet CDC Surgical Wound Classification except Class IV or deep incisional/organ space infections
You will not qualify if you...
- Wound suspicious for cancer or diagnosed with carcinoma
- More than two weeks of immune-suppressant treatment or topical steroids to wound within 1 month before first study visit or planned during study
- Use of selective COX-2 inhibitors like Celecoxib
- Participation in investigational drug or device studies within 30 days before study
- History of radiation at wound site
- Use or need of prohibited therapies for the wound
- Diagnosis of HIV, Hepatitis C, or other contagious diseases
- Conditions compromising study completion or poor medical adherence
- Pregnancy or breastfeeding
- Diabetes with poor control (HbA1c >12%) within 90 days before randomization
- End-stage renal disease with serum creatinine >3.0 mg/dL within 6 months
- Body mass index over 55
- Greater than 30% change in wound area between first and second study visits for diabetic foot ulcers
- Wagner 2 wounds requiring bone debridement
- Osteomyelitis or bone infection of affected foot or leg within 30 days prior to randomization
- For venous leg ulcers: secondary post thrombotic, venous obstruction with or without reflux, lipodermato sclerosis, or atrophic blanche
- For surgical dehisced wounds: Sandy Grade 3 wounds with exposed organs or severe infection
- For traumatic wounds: CDC Class IV dirty infected wounds or deep incisional and organ space surgical site infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MCR Health, Inc.
Bradenton, Florida, United States, 34208
Actively Recruiting
Research Team
S
Sharona Segal-Leibovich
CONTACT
A
Amy Jo Johnson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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