Diabetic Foot UlcerNCT04240574
Debritom - Micro Water Jet Technology and Wound Healing
A study testing Debritom in people with Diabetic Foot Ulcer and Non-healing Wound, run by Stephanie Wu at 1 site in United States.
Trial summary
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
- What is being tested?
- Debritom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 6 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosalind Franklin University Health Clinics
North Chicago, Illinois, 60064
About this study
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
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer, Venous Ulcer
- Being tested
- Debritom
- Medical subject headings
- Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebritomDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Micro Water Jet Technology (Debritom) | Other | 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. Receives: Device: Debritom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of Ulcers
The extent and size of ulcers (summation of the products of the long x short axis for all ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or when the ulcer is healed, whichever is sooner.
Measured: Up to 20 weeks or when the ulcer is healed, whichever is sooner.
Leg Rest Pain Score
Leg rest pain score - visual analogue scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain) during screening and on all clinic visits up to 20 weeks, or when the ulcer is healed, whichever is sooner.
Measured: up to 20 weeks, or when the ulcer is healed, whichever is sooner
Pain During Debridement Score
Pain during Debridement score - VAS graded from 0 (pain free) to Grade 10 (maximum pain) during on all clinical visits when debridement is performed for up to 20 weeks, sooner pending wound healing.
Measured: up to 20 weeks, sooner pending wound healing.
Subjects Feedback
Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Measured: At end of their study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start24 Jan 2020
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Why it stopped: Due to pandemic we were not able to recruit patients for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie Wu, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240574
- Sponsor's protocol ID
- MDX-DEB-001
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2020
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Will not share
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04240574
- Acronym / sponsor ID
- MDX-DEB-001
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer, Venous Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to pandemic we were not able to recruit patients for this study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Stephanie WuUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 27 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro Water Jet Technology (Debritom) | Other | Device: DebritomDebritom 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debritomhydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner. | Device | Micro Water Jet Technology (Debritom) |
Primary outcome
Size of Ulcers
Time frame: Up to 20 weeks or when the ulcer is healed, whichever is sooner.
The extent and size of ulcers (summation of the products of the long x short axis for all ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or when the ulcer is healed, whichever is sooner.
Leg Rest Pain Score
Time frame: up to 20 weeks, or when the ulcer is healed, whichever is sooner
Leg rest pain score - visual analogue scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain) during screening and on all clinic visits up to 20 weeks, or when the ulcer is healed, whichever is sooner.
Pain During Debridement Score
Time frame: up to 20 weeks, sooner pending wound healing.
Pain during Debridement score - VAS graded from 0 (pain free) to Grade 10 (maximum pain) during on all clinical visits when debridement is performed for up to 20 weeks, sooner pending wound healing.
Subjects Feedback
Time frame: At end of their study participation
Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Will not share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debritom in people with Diabetic Foot Ulcer and Non-healing Wound, run by Stephanie Wu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of Ulcers (time frame: Up to 20 weeks or when the ulcer is healed, whichever is sooner.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.