Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT02045303
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2014-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
Sponsor:
Texas Health Resources
Organization:
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 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
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
Study Oversight
Has Oversight DMC:
False
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?: