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Due to pandemic we were not able to recruit patients for this study
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This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debritom | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | At end of their study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosalind Franklin University Health Clinics | North Chicago | Illinois | 60064 | United States |
Will not share
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Up to 20 participants may be recruited. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Unable to complete the study due to national pandemic. We were only able to have two participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Treatments | All study subjects will receive micro water jet technology debridement as opposed to traditional debridement using instruments or other means of debridement. Other aspects of subjects wound care protocol will remain unchanged. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not collected. | Posted | Up to 20 weeks or when the ulcer is healed, whichever is sooner. |
|
Six months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants, which was only two for this study due study terminating due to the pandemic. |
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Early termination of study due to pandemic. The study was not able to be completed.
The early termination lead to only two subjects taking part of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacque Ortiz | Rosalind Franklin University | 847-578-8423 | jacquelyn.ortiz@rosalindfranklin.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2019 | Nov 17, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2019 | Oct 24, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Primary | 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. | Data not collected. | Posted | up to 20 weeks, or when the ulcer is healed, whichever is sooner |
|
|
| Primary | 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. | Data not collected. | Posted | up to 20 weeks, sooner pending wound healing. |
|
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| Primary | Subjects Feedback | Subjects feedback regarding their debridement experience with micro water jet technology will be collected on all clinical visits when debridement is performed. | Data not collected. | Posted | At end of their study participation |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |