Viewing Study NCT02045303



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Last Modification Date: 2024-10-26 @ 11:18 AM
Study NCT ID: NCT02045303
Status: COMPLETED
Last Update Posted: 2022-01-24
First Post: 2014-01-20

Brief Title: Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound The VIP Ultrasound Protocol
Sponsor: Texas Health Resources
Organization: Texas Health Resources

Study Overview

Official Title: Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy The VIP Ultrasound Protocol
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 seccm2 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 andor 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 patients 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 patients 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 andor wound volume andor wound bed quality after 4 consecutive weeks of treatment
3 consecutive missed visits or a total of 7 missed visits

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None