Diabetic Foot Ulcer, Non-Healing Ulcer of Skin, Non-healing Wound, Venous Leg Ulcer, Venous Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEDebritom
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.
Sponsors
Stephanie Wu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of Ulcers | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Study Treatments |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: up to 20 weeks, or when the ulcer is healed, whichever is sooner
Population: Data not collected.
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.
Time frame: up to 20 weeks, sooner pending wound healing.
Population: Data not collected.
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.
Time frame: Up to 20 weeks or when the ulcer is healed, whichever is sooner.
Population: Data not collected.
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.
Time frame: At end of their study participation
Population: Data not collected.