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Debritom - Micro Water Jet Technology and Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240574
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Stephanie Wu, DPM, MS, Rosalind Franklin University of Medicine and Science

Brief Summary:
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Non-healing Wound Non-Healing Ulcer of Skin Venous Leg Ulcer Venous Ulcer Device: Debritom Not Applicable

Detailed Description:
This is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. The study will enroll up to 20 subjects. Subjects will undergo screening evaluations to determine eligibility to enroll in the study. All study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. The other aspects of subjects wound care protocol will remain unchanged. In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: A Prospective Cohort Evaluating the Efficacy of Micro Water Jet Technology in the Debridement and Healing of Chronic Lower Extremity Ulcers
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Micro Water Jet Technology (Debritom)

Debritom is a hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.

All subject will get the Debritom.

Device: Debritom
hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.




Primary Outcome Measures :
  1. Healing [ Time Frame: 20 weeks or sooner pending wound healing as defined by 100% re-epithelialization ]
    The primary objective of the study is to assess the clinical efficacy of micro water jet technology in the debridement of chronic lower extremity ulcers in terms of wound size.

  2. Healing [ Time Frame: 20 weeks or sooner pending wound healing as defined by 100% re-epithelialization ]
    The primary objective of the study is to assess the clinical efficacy of micro water jet technology in the healing of chronic lower extremity ulcers in terms of depth/extent.

  3. Healing [ Time Frame: 20 weeks or sooner pending wound healing as defined by 100% re-epithelialization ]
    The primary objective of the study is to assess the clinical efficacy of micro water jet technology in the healing of chronic lower extremity ulcers in terms of percent wound reduction.

  4. Healing [ Time Frame: 20 weeks or sooner pending wound healing as defined by 100% re-epithelialization ]
    The primary objective of the study is to assess the clinical efficacy of micro water jet technology in the healing of chronic lower extremity ulcers in terms of percent wound healing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 18 or older
  • The ability and willingness to provide Informed consent
  • Presence of a chronic lower extremity ulcer
  • Chronic ulcer is defined as that greater than 4 weeks in duration.
  • Subject's informed consent for participation prior to proceeding with micro water jet technology debridement
  • Patient's ulcer cannot exhibit any gross clinical signs of infection.
  • Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
  • Patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks.

Exclusion Criteria:

  • Patients with active wound infection, or untreated osteomyelitis
  • Patients with dementia, or impaired cognitive function
  • Patients who are unable or unwilling to participate in all procedures and follow up evaluations
  • Patient has Active Charcot foot
  • Patient with malignant wounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240574


Contacts
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Contact: Jacquelyn Ortiz 8475788423 jacquelyn.ortiz@rosalindfranklin.edu

Locations
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United States, Illinois
Rosalind Franklin University Health Clinics Recruiting
North Chicago, Illinois, United States, 60064
Contact: Jacquelyn Ortiz    847-578-8423    jacquelyn.ortiz@rosalindfranklin.edu   
Contact       jacquelyn.ortiz@rosalindfranklin.edu   
Principal Investigator: Stephanie Wu, DPM         
Sponsors and Collaborators
Dr. Stephanie Wu, DPM, MS
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Responsible Party: Dr. Stephanie Wu, DPM, MS, Principal Investigator, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT04240574    
Other Study ID Numbers: MDX-DEB-001
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Leg Ulcer
Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins