NCT02045303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

January 24, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

January 20, 2014

Results QC Date

November 11, 2016

Last Update Submit

January 20, 2022

Conditions

Chronic Ulcer of Lower Extremity

Keywords

Sub-acute woundChronic woundWoundMISTSoringContact UltrasoundNoncontact ultrasoundWound CareVIP Ultrasound ProtocolUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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.

    Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.

Secondary Outcomes (2)

  • 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.

  • 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.

Other Outcomes (1)

  • 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.

Study Arms (1)

Ambulatory Wound Clinic

EXPERIMENTAL

Intervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic.

Device: Contact Ultrasound TherapyDevice: Noncontact Ultrasound Therapy

Interventions

Contact Ultrasound TherapyDEVICE

Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.

Also known as: Soring, Sonoca-180
Ambulatory Wound Clinic
Noncontact Ultrasound TherapyDEVICE

Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.

Also known as: Celleration Inc, MIST Therapy
Ambulatory Wound Clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Health Resources - Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Lisley Viana, Physical Therapist
Organization
Texas Health Resources Presbyterian Hospital of Dallas
lisleyviana@texashealth.org
214-345-4334

Study Officials

  • Lisley Viana, PTMS

    Texas Health Resources - Presbyterian Hospital of Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 24, 2022

Results First Posted

January 24, 2022

Record last verified: 2022-01

Locations

US(1)