Chronic Ulcer of Lower Extremity
Conditions
Keywords
Sub-acute wound, Chronic wound, Wound, MIST, Soring, Contact Ultrasound, Noncontact ultrasound, Wound Care, VIP Ultrasound Protocol, Ultrasound
Brief summary
Wound healing rate is higher when contact ultrasound therapy is followed by noncontact ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.
Detailed description
This prospective pilot study is designed to evaluate the clinical effectiveness of a wound care ultrasound treatment protocol for sub-acute or chronic wounds of the lower extremity and of any etiology. The Viana-Pompeo (VIP) ultrasound protocol consists of high intensity, low frequency, contact ultrasound therapy (with Sonoca-180) followed by low intensity, low-frequency, noncontact ultrasound therapy (with MIST Therapy). Previously published healing rates for each of the ultrasonic therapy modalities will be used as a comparison. The Physical Therapist will perform the initial assessment and treatment, and devise an individualized plan of care that involves contact ultrasound followed by noncontact ultrasound. Subjects may remain in the study for up to 12 weeks, or up to when end of study criteria is met. Transition from contact mode to noncontact mode will happen when: \- Wound is sufficiently clean with ≤ 20% of necrotic tissue or adherent slough. OR \- \>= 80% of soft slough is easily removed from the wound bed with mechanical or selective debridement before or after treatment OR \- Wound bed quality has failed to progress after 3 consecutive contact ultrasound treatments For the purposes of this study, treatments will be performed 3 times a week. Treatment time will be dependent on the wound area, at least 20 sec/cm2, per standard protocol. Only the wounds present during Physical Therapy (PT) initial assessment will be included in the research. If the patient develops new wounds during the course of the research, the patient will receive appropriate treatment, but such wounds will not be part of the study. Patients in the wound clinic setting are allowed to perform home dressing changes as ordered by the physician in addition to the dressing changes performed by the therapist or wound clinic nurse on clinic visit days. Patients and/or caregivers will be trained in dressing changes techniques and must understand the procedure prior to performing dressing changes on their own. In addition to ultrasonic treatment and dressing changes, wound debridement may be performed each visit as needed. Digital photography and wound measurements will also be performed weekly and as needed. End of PT wound therapy may be before, at, or after the end of the study period. The beginning of the MIST therapy will depend on the individual characteristics and wound needs. A minimum of 4 MIST treatments must be completed for a patient's data to be included the data analysis in the acute care setting. A minimum of 2 treatments per week (goal of 3 per week) must be reached for the 12 week period for a patient's data to be included in the data analysis. Study Endpoints Primary endpoint: * Wound area reduction * Percent granulation tissue * Length of the study for ambulatory subjects: 12 weeks from Start of Contact Ultrasound therapy Secondary endpoint: * Wound closure at any point within the length of study * Failure to note improvement in wound area, and/or wound volume, and/or wound bed quality after 4 consecutive weeks of treatment. * 3 consecutive missed visits, or a total of 7 missed visits
Interventions
DEVICEContact Ultrasound Therapy
Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
DEVICENoncontact Ultrasound Therapy
Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Sponsors
Celleration, Inc.
Texas Health Resources
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
* Patient is referred to Physical Therapy for contact ultrasound (which is included in the VIP protocol); * Lower extremity (including foot) wound(s) of any etiology; * Wound(s) presenting with slough, necrotic tissue, and/or non-viable tissue requiring debridement; * Wound is present for 4 weeks or longer at the start of ultrasonic therapy; * Insurance approval is obtained for Contact and Noncontact ultrasound treatments, in the ambulatory setting; * Patient is 18 years of age or older; * Female patient attesting not to be pregnant; * Not undergoing Vacuum Assisted Closure (VAC) therapy.
Exclusion criteria
* Patient is referred to Physical Therapy for noncontact ultrasound only; * Wound(s) not on lower extremity; * Clean wound(s) that do not require debridement; * Wound onset less than 4 weeks prior to the start of ultrasonic therapy; * Malignancies on the treatment area; * Patients in the ambulatory setting whose insurance did not approve them for both contact and noncontact ultrasound therapy; * Patient is under 18 years of age; * Female patient attesting to be pregnant; * VAC Therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Wound Area | Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | Mean and Standard Deviation of the group's total wound area at day one and last treatment day. Wound area was measured as Length x Width. This is to assess the change in area, in order to assess wound progress towards closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Wound Volume | Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | Mean and Standard Deviation of the group's total wound volume at day one and last treatment day. Wound volume was measured as Length x Width X Depth (when able to determine depth). This is to assess the change in volume, in order to assess wound progress towards closure. |
| Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | Mean and Standard Deviation of the group's percent adherent and/or non-adherent slough present in the wound bed at day one and last treatment day. This is to assess the change in slough/eschar. This is to determine progression from contact to noncontact ultrasound therapy, as well as to determine progress of wound bed quality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit | Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then. | Mean and Standard Deviation of the group's total percent of granulation tissue present in the wound bed at day one and last treatment day. This is to assess the change in granulation, in order to assess progress of wound bed quality. |
Countries
United States
Participant flow
Recruitment details
This study enrolled subjects who had sub-acute or chronic lower leg wound requiring debridement, who were coming to the outpatient wound care clinic for follow up with wound care doctor.
Pre-assignment details
The wound care doctor wrote orders for ultrasound therapy performed by Physical Therapist (PT). Throughout the open enrollment phase, the PT screened referred patients to check if they met study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Wound Age Between 4 and 21 Weeks Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks or up to the time of wound closure. | 4 |
| Wound Age Between 4 and 21 Weeks Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks or up to the time of wound closure. | 4 |
| Wound Age >=47 Weeks Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks. | 2 |
| Wound Age >=47 Weeks Both groups underwent the same protocol of contact ultrasound followed by non-contact ultrasound therapy, with the goal of 3x/week treatment frequency. Study data for this group was collected over a period of 12 weeks. | 8 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Wound Age Between 4 and 21 Weeks | Total | Wound Age >=47 Weeks |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Associated Diagnosis 3rd Degree Burn | 0 Wounds | 5 Wounds | 5 Wounds |
| Associated Diagnosis Above Knee Amputation (opposite limb) | 1 Wounds | 1 Wounds | 0 Wounds |
| Associated Diagnosis Cat Bite | 1 Wounds | 1 Wounds | 0 Wounds |
| Associated Diagnosis Diabetes | 2 Wounds | 5 Wounds | 3 Wounds |
| Associated Diagnosis Peripheral Artery Disease | 2 Wounds | 2 Wounds | 0 Wounds |
| Associated Diagnosis Post-Surgical Debridement | 1 Wounds | 1 Wounds | 0 Wounds |
| Associated Diagnosis S/p Ganglion Cyst Removal | 1 Wounds | 1 Wounds | 0 Wounds |
| Associated Diagnosis Stage IV Pressure Ulcer | 1 Wounds | 1 Wounds | 0 Wounds |
| Associated Diagnosis Vasculitis | 0 Wounds | 3 Wounds | 3 Wounds |
| Associated Diagnosis Venous Insufficiency | 0 Wounds | 5 Wounds | 5 Wounds |
| Initial Wound Area | 10.12 cm^2 | 8.66083 cm^2 | 7.93125 cm^2 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
| Wound Location Ankle | 0 Wounds | 1 Wounds | 1 Wounds |
| Wound Location Foot/Heel/Toes | 3 Wounds | 5 Wounds | 2 Wounds |
| Wound Location Knee | 0 Wounds | 1 Wounds | 1 Wounds |
| Wound Location Lower Leg | 1 Wounds | 5 Wounds | 4 Wounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Total Wound Area
Mean and Standard Deviation of the group's total wound area at day one and last treatment day. Wound area was measured as Length x Width. This is to assess the change in area, in order to assess wound progress towards closure.
Time frame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wound Age Between 4 and 21 Weeks | Total Wound Area | Initial Wound Area | 7.93125 Squared centimiters | Standard Deviation 5.96128 |
| Wound Age Between 4 and 21 Weeks | Total Wound Area | Wound Area on Last Study Visit | 1.3275 Squared centimiters | Standard Deviation 2.61515 |
| Wound Age >=47 Weeks | Total Wound Area | Initial Wound Area | 7.93125 Squared centimiters | Standard Deviation 5.96128 |
| Wound Age >=47 Weeks | Total Wound Area | Wound Area on Last Study Visit | 8.80875 Squared centimiters | Standard Deviation 7.73304 |
Secondary
Total Wound Volume
Mean and Standard Deviation of the group's total wound volume at day one and last treatment day. Wound volume was measured as Length x Width X Depth (when able to determine depth). This is to assess the change in volume, in order to assess wound progress towards closure.
Time frame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wound Age Between 4 and 21 Weeks | Total Wound Volume | Initial Wound Volume | 9.561 cubic centimeter | Standard Deviation 9.94704 |
| Wound Age Between 4 and 21 Weeks | Total Wound Volume | Wound Volume on Last Study Visit | 0.394 cubic centimeter | Standard Deviation 0.78401 |
| Wound Age >=47 Weeks | Total Wound Volume | Initial Wound Volume | 2.67475 cubic centimeter | Standard Deviation 2.73782 |
| Wound Age >=47 Weeks | Total Wound Volume | Wound Volume on Last Study Visit | 2.086 cubic centimeter | Standard Deviation 1.9324 |
Secondary
Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit
Mean and Standard Deviation of the group's percent adherent and/or non-adherent slough present in the wound bed at day one and last treatment day. This is to assess the change in slough/eschar. This is to determine progression from contact to noncontact ultrasound therapy, as well as to determine progress of wound bed quality.
Time frame: Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Wound Age Between 4 and 21 Weeks | Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Wounds w/ slough/eschar Reduction on visit 2 | 4 Wounds |
| Wound Age Between 4 and 21 Weeks | Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Wounds w/ slough/eschar Reduction on last visit | 4 Wounds |
| Wound Age >=47 Weeks | Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Wounds w/ slough/eschar Reduction on visit 2 | 8 Wounds |
| Wound Age >=47 Weeks | Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit | Wounds w/ slough/eschar Reduction on last visit | 7 Wounds |
Other Pre-specified
Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit
Mean and Standard Deviation of the group's total percent of granulation tissue present in the wound bed at day one and last treatment day. This is to assess the change in granulation, in order to assess progress of wound bed quality.
Time frame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wound Age Between 4 and 21 Weeks | Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit | Initial Granulation | 22.5 % Granulation | Standard Deviation 17.07825 |
| Wound Age Between 4 and 21 Weeks | Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit | Granulation on last visit | 100 % Granulation | Standard Deviation 0 |
| Wound Age >=47 Weeks | Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit | Initial Granulation | 21.75 % Granulation | Standard Deviation 24.97284 |
| Wound Age >=47 Weeks | Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit | Granulation on last visit | 55.125 % Granulation | Standard Deviation 38.93745 |