Trial Outcomes & Findings for Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol (NCT NCT02045303)
NCT ID: NCT02045303
Last Updated: 2022-01-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Results posted on
2022-01-24
Participant Flow
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.
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.
Unit of analysis: Wounds
Participant milestones
| Measure |
Ambulatory Wound Clinic - Wound Age Between 4 and 21 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age between 4 and 21 weeks
|
Ambulatory Wound Clinic - Wound Age Between 22 and 46 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age between 22 and 46 weeks
|
Ambulatory Wound Clinic - Wound Age >= 47 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age \>= 47 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
6 6
|
3 10
|
2 8
|
|
Overall Study
COMPLETED
|
4 4
|
0 0
|
2 8
|
|
Overall Study
NOT COMPLETED
|
2 2
|
3 10
|
0 0
|
Reasons for withdrawal
| Measure |
Ambulatory Wound Clinic - Wound Age Between 4 and 21 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age between 4 and 21 weeks
|
Ambulatory Wound Clinic - Wound Age Between 22 and 46 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age between 22 and 46 weeks
|
Ambulatory Wound Clinic - Wound Age >= 47 Weeks
Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.
Contact Ultrasound Therapy: Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound Therapy: Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
Wound age \>= 47 weeks
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
Baseline characteristics by cohort
| Measure |
Wound Age Between 4 and 21 Weeks
n=4 Wounds
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.
|
Wound Age >=47 Weeks
n=8 Wounds
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.
|
Total
n=12 Wounds
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Wound Location
Ankle
|
0 Wounds
n=12 Wounds
|
1 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Wound Location
Foot/Heel/Toes
|
3 Wounds
n=12 Wounds
|
2 Wounds
n=8 Wounds
|
5 Wounds
n=12 Wounds
|
|
Wound Location
Knee
|
0 Wounds
n=12 Wounds
|
1 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Wound Location
Lower Leg
|
1 Wounds
n=12 Wounds
|
4 Wounds
n=8 Wounds
|
5 Wounds
n=12 Wounds
|
|
Initial Wound Area
|
10.12 cm^2
n=12 Wounds
|
7.93125 cm^2
n=8 Wounds
|
8.66083 cm^2
n=12 Wounds
|
|
Associated Diagnosis
S/p Ganglion Cyst Removal
|
1 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Stage IV Pressure Ulcer
|
1 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Diabetes
|
2 Wounds
n=12 Wounds
|
3 Wounds
n=8 Wounds
|
5 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Peripheral Artery Disease
|
2 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
2 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Above Knee Amputation (opposite limb)
|
1 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Post-Surgical Debridement
|
1 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Vasculitis
|
0 Wounds
n=12 Wounds
|
3 Wounds
n=8 Wounds
|
3 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Cat Bite
|
1 Wounds
n=12 Wounds
|
0 Wounds
n=8 Wounds
|
1 Wounds
n=12 Wounds
|
|
Associated Diagnosis
3rd Degree Burn
|
0 Wounds
n=12 Wounds
|
5 Wounds
n=8 Wounds
|
5 Wounds
n=12 Wounds
|
|
Associated Diagnosis
Venous Insufficiency
|
0 Wounds
n=12 Wounds
|
5 Wounds
n=8 Wounds
|
5 Wounds
n=12 Wounds
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Wound Age Between 4 and 21 Weeks
n=4 Wounds
Wounds age between 4 and 21 weeks at the day of initial visit.
|
Wound Age >=47 Weeks
n=8 Wounds
Wounds age \>=47 weeks at the day of initial visit.
|
|---|---|---|
|
Total Wound Area
Initial Wound Area
|
7.93125 Squared centimiters
Standard Deviation 5.96128
|
7.93125 Squared centimiters
Standard Deviation 5.96128
|
|
Total Wound Area
Wound Area on Last Study Visit
|
1.3275 Squared centimiters
Standard Deviation 2.61515
|
8.80875 Squared centimiters
Standard Deviation 7.73304
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Wound Age Between 4 and 21 Weeks
n=4 Wounds
Wounds age between 4 and 21 weeks at the day of initial visit.
|
Wound Age >=47 Weeks
n=8 Wounds
Wounds age \>=47 weeks at the day of initial visit.
|
|---|---|---|
|
Total Wound Volume
Initial Wound Volume
|
9.561 cubic centimeter
Standard Deviation 9.94704
|
2.67475 cubic centimeter
Standard Deviation 2.73782
|
|
Total Wound Volume
Wound Volume on Last Study Visit
|
0.394 cubic centimeter
Standard Deviation 0.78401
|
2.086 cubic centimeter
Standard Deviation 1.9324
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Wound Age Between 4 and 21 Weeks
n=4 Wounds
Wounds age between 4 and 21 weeks at the day of initial visit.
|
Wound Age >=47 Weeks
n=8 Wounds
Wounds age \>=47 weeks at the day of initial visit.
|
|---|---|---|
|
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
|
8 Wounds
|
|
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
|
7 Wounds
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Wound Age Between 4 and 21 Weeks
n=4 Wounds
Wounds age between 4 and 21 weeks at the day of initial visit.
|
Wound Age >=47 Weeks
n=8 Wounds
Wounds age \>=47 weeks at the day of initial visit.
|
|---|---|---|
|
Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit
Initial Granulation
|
22.5 % Granulation
Standard Deviation 17.07825
|
21.75 % Granulation
Standard Deviation 24.97284
|
|
Wounds With Granulation Present on Visit 1 and Wounds With Granulation Present at Last Visit
Granulation on last visit
|
100 % Granulation
Standard Deviation 0
|
55.125 % Granulation
Standard Deviation 38.93745
|
Adverse Events
Wound Age Between 4 and 21 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wound Age >=47 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisley Viana, Physical Therapist
Texas Health Resources Presbyterian Hospital of Dallas
Phone: 214-345-4334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place