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

NCT04564443 | Active Not Recruiting

• 1 other identifier: MEDX-DT-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Diabetic Foot Ulcer; Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Proportion of wounds completely healed at or before 16 weeks

  examine the time it takes the wound to heal over a 16 week period

  16 weeks

Secondary Outcomes (7)

• Incidence of any index wound-related cellulitis or infection by 16 weeks

  16 weeks

• Cost of treatment, including any index wound-related complications, by 16 weeks

  16 weeks

• Percent Area Reduction at 16 weeks.

  16 weeks

• Cost of hospitalization for any index wound-related event, including any wound recurrence involving the area of the index wound by 16 weeks

  16 weeks

• Incidence of hospitalization between randomization and EOS for any index wound-related event, including any wound recurrence involving the area of the index wound

  16 weeks

Study Arms (2)

(Medaxis Debritom+™) micro fluid jet wound therapy

EXPERIMENTAL

Medaxis Debritom+™ is a high-quality, micro fluid jet therapy device designed to remove fibrin, necrotic tissue, and biofilm from wound surfaces by mechanical cleaning and stimulation of the diabetic foot wound

Other: Medaxis Debritom+; Other: Additional Outer Dressing Application; Other: Offloading; Other: Fibracol Wound Dressing

Sharp Surgical Debridement

ACTIVE COMPARATOR

Use of a surgical scalpel or curette to remove fibrin, necrotic tissue and biofilm from wound surfaces by mechanically cleaning the wound

Other: Sharp Surgical Debridement; Other: Additional Outer Dressing Application; Other: Offloading; Other: Fibracol Wound Dressing

Interventions

Medaxis Debritom+ OTHER

Advanced micro fluid jet therapy to clean and stimulate wound

(Medaxis Debritom+™) micro fluid jet wound therapy

Sharp Surgical Debridement OTHER

Scalpel or Curette to clean and debride wound

Sharp Surgical Debridement

Additional Outer Dressing Application OTHER

Application of moisture retentive dressing, and a multi layer compression dressing

(Medaxis Debritom+™) micro fluid jet wound therapy; Sharp Surgical Debridement

Offloading OTHER

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

Also known as: Pressure Relief

(Medaxis Debritom+™) micro fluid jet wound therapy; Sharp Surgical Debridement

Fibracol Wound Dressing OTHER

Application of a collagen alginate dressing

Also known as: Calcium Alginate

(Medaxis Debritom+™) micro fluid jet wound therapy; Sharp Surgical Debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Presence of a diabetic foot ulcer (DFU) meets all of the following features: Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to the ligament, tendon, joint capsule or fascia
• At least 50% below the medial aspect of the malleolus
• Without abscess or osteomyelitis
• The index ulcer will be the largest ulcer if two or more DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• The index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
• The index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1.
• The index ulcer has been offloaded for at least 14 days prior to randomization.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, IUD's, barriers or abstinence) during the course of the study and undergo pregnancy tests.
• Subject understands and is willing to participate in the clinical study and can comply - with weekly visits.
• Subjects must have read and signed the IRB approved ICF before screening procedures are undertaken.

You may not qualify if:

• The index ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
• The index ulcer, in the opinion of the investigator, is suspicious for cancer or has a positive carcinoma diagnosis.
• Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
• Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
• History of radiation at the ulcer site (regardless of time since last radiation treatment).
• Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 6.2.4 of this protocol for a list of prohibited medications and therapies).
• Subjects with a previous diagnose of HIV, Hepatitis C, or other contagious diseases
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or the subject has a known history of poor adherence with medical treatment.
• Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c \> 12.0 within 90 days of randomization.
• Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
• Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.

Sponsors & Collaborators

• Medaxis, LLC: lead
• Professional Education and Research Institute: collaborator

Study Sites (6)

CCR Research

San Francisco, California, 94115, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Foot and Ankle Associates of the Mid-Atlantic

Frederick, Maryland, 21703, United States

Location

Foot and Ankle Associates of the Mid-Atlantic

Raleigh, North Carolina, 27609, United States

Location

Lower Extremity Institute for Research and Therapy, LLC

Youngstown, Ohio, 44512, United States

Location

Foot and Ankle Associates of the Mid-Atlantic

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Alginates

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Robert Galiano, MD

  Northwestern University School of Medicine

  PRINCIPAL INVESTIGATOR

• David Armstrong, DPM, MD, PhD

  University of Southern California; Keck School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: September 11, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)