Diabetic Foot Ulcer Clinical Trial
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
Verified date | March 2023 |
Source | Rosalind Franklin University of Medicine and Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
Status | Terminated |
Enrollment | 2 |
Est. completion date | August 6, 2021 |
Est. primary completion date | August 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rosalind Franklin University Health Clinics | North Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Stephanie Wu |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Up to 20 weeks or when the ulcer is healed, whichever is sooner. | |
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. | 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. | up to 20 weeks, sooner pending wound healing. | |
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. | At end of their study participation |
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