N/A
N=11
Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
Chronic Ulcer of Lower Extremity
Bottom Line
View on ClinicalTrials.gov: NCT02045303 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Total Wound Area — 7.93125; 7.93125; 1.3275; 8.80875 Squared centimiters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contact Ultrasound Therapy (Device); Noncontact Ultrasound Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Health Resources
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Wound Area |
7.93125; 7.93125; 1.3275; 8.80875 | — |
| SECONDARY Total Wound Volume |
9.561; 2.67475; 0.394; 2.086 | — |
| SECONDARY Wounds With Slough/Eschar Reduction on Visit 2 and Wounds With Slough/Eschar Reduction at Last Visit |
4; 8; 4; 7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02045303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.