Chronic Ulcer of Lower ExtremityNCT02045303
Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
A study testing Contact Ultrasound Therapy and Noncontact Ultrasound Therapy in people with Chronic Ulcer of Lower Extremity, run by Texas Health Resources at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcer of Lower Extremity
- What is being tested?
- Contact Ultrasound Therapy and Noncontact Ultrasound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Patient is under 18 years of age;
- Female patient attesting to be pregnant;
- VAC Therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Health Resources - Presbyterian Hospital of Dallas
Dallas, Texas, 75231
About this study
Official title: Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy: The VIP Ultrasound Protocol
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.
Read the 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
- Conditions
- Chronic Ulcer of Lower Extremity
- Being tested
- Contact Ultrasound Therapy, Noncontact Ultrasound Therapy
- Keywords
- Sub-acute wound, Chronic wound, Wound, MIST, Soring, Contact Ultrasound, Noncontact ultrasound, Wound Care, VIP Ultrasound Protocol, Ultrasound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact Ultrasound TherapyDevice
Also called Soring, Sonoca-180
Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
Noncontact Ultrasound TherapyDevice
Also called Celleration Inc, MIST Therapy
Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Contact Ultrasound Therapy; Device: Noncontact Ultrasound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Ulcer of Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Health Resources
- Sponsor type
- University, hospital or other
- Collaborators
- Celleration, Inc.
- Responsible party
- Principal investigator, Lisley Viana, Texas Health Resources
- Investigators
- Lisley Viana, PTMS, Principal investigator, Texas Health Resources - Presbyterian Hospital of Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045303
- Sponsor's protocol ID
- Pro00004597
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2014
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Rate of Chronic and Sub-Acute Lower Extremity Ulcers Treated With Contact Ultrasound Followed by MIST Therapy: The VIP Ultrasound Protocol
- ClinicalTrials.gov ID
- NCT02045303
- Acronym / sponsor ID
- Pro00004597
- Conditions
- Chronic Ulcer of Lower Extremity
- Keywords
- Sub-acute wound, Chronic wound, Wound, MIST, Soring, Contact Ultrasound, Noncontact ultrasound, Wound Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Texas Health ResourcesUniversity, hospital or other
- Collaborators
- Celleration, Inc.
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Wound Clinic | Experimental | Device: Contact Ultrasound Therapy, Device: Noncontact Ultrasound TherapyIntervention with contact ultrasound therapy and noncontact ultrasound therapy following the study protocol on subjects receiving care at the wound clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contact Ultrasound TherapyAlso: Soring, Sonoca-180Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy. | Device | Ambulatory Wound Clinic |
| Noncontact Ultrasound TherapyAlso: Celleration Inc, MIST TherapyTransition from contact to noncontact ultrasound when criteria for transition is met per our protocol. | Device | Ambulatory Wound Clinic |
Primary outcome
Total Wound Area
Time frame: 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.
2 secondary outcomes
Total Wound Volume
Time frame: 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
Time frame: Day 2 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisley Viana, PTMS principal investigator
Texas Health Resources - Presbyterian Hospital of Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact Ultrasound Therapy and Noncontact Ultrasound Therapy in people with Chronic Ulcer of Lower Extremity, run by Texas Health Resources at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Wound Area (time frame: Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.