πŸ›οΈ Verified NIH Record β€’ Updated 2024-11-19

A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot (NCT04564443)

A Multi-center, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot

πŸ”΅ Active, Not Recruiting Observational / Diagnostic πŸ“‹ Clinical Research Protocol Sponsor: Medaxis, LLC

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+β„’ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.

Who can join: Review the eligibility criteria below.

Location: CCR Research β€” San Francisco, California

Age range: 18 Years

πŸ§ͺ Interventions in This Study

  • Medaxis Debritom+ (OTHER)
  • Sharp Surgical Debridement (OTHER)
  • Additional Outer Dressing Application (OTHER)
  • Offloading (OTHER)
  • Fibracol Wound Dressing (OTHER)

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (6 Sites)

  • CCR Research β€” San Francisco, California
  • Doctors Research Network β€” South Miami, Florida
  • Foot and Ankle Associates of the Mid-Atlantic β€” Frederick, Maryland
  • Foot and Ankle Associates of the Mid-Atlantic β€” Raleigh, North Carolina
  • Lower Extremity Institute for Research and Therapy, LLC β€” Youngstown, Ohio
  • Foot and Ankle Associates of the Mid-Atlantic β€” Salem, Virginia

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—