Varicose UlcerNCT01671748

MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

A study testing MIST ultrasound therapy in people with Varicose Ulcer, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Varicose Ulcer
What is being tested?: MIST ultrasound therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2012to Dec 2013
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

Venous leg ulcers (as diagnosed by the clinician)
Ankle Brachial Pressure Index (ABPI) >0.8
If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer
18 years or older
Ulcer size of 5 cm^2 - 100 cm^2 (with no longest length being greater than 10 cm) at randomisation point (week 5)
Mobile enough to attend clinic
Index ulcer between 6 weeks and 5 years duration prior to screening date

Who cannot join

Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months
Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics
Renal failure
Index ulcer has exposed tendons, ligaments, muscle, or bone
Osteomyelitis or cellulitis or gangrene in study limb
Subjects with amputation above a trans metatarsal amputation (TMA) in the study limb

Show all 19Show fewer

Subjects with active malignancy on the study limb
Index ulcer that is of arterial disease aetiology
Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 6 weeks post-operatively
Planned surgical procedure during the study period for the index wound
Prior skin replacement, negative pressure therapy, ultrasound therapy applied to the index wound 2 weeks before screening
Oral or IV antibiotics within 48 hours of baseline measurements
Growth factor therapy within previous 14 days of screening date
Currently receiving or has received radiation or chemotherapy within 3 months of randomisation
Pregnant or breast feeding women
Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
Subject's wound would require ultrasound near an electronic implant or prosthesis
Subjects lacking capacity to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Wound Healing Research Unit, Cardiff University
Cardiff, CF14 4XN

Other trials in United Kingdom

About this study

Official title: Pragmatic Randomised Controlled Trial of MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers.

Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST ultrasound system is a noncontact device which delivers low frequency ultrasound through a gentle saline mist directed at a patient's wound. This study aims to determine whether the use of the MIST device used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. This will be assessed by measuring any reduction in wound size in the two groups after receiving 8 weeks of either Standard Care once a week or MIST combined with Standard Care three times a week.

Read the detailed description

Venous leg ulcers (VLUs) are wounds which are often chronic and difficult to heal. VLUs affect between 1 and 3.2 people per 1000; they cause pain, reduced mobility and impact negatively on patients' quality of life (QoL). Standard treatment for patients with VLUs is the application of strong, sustained compression with bandages or stockings. This pragmatically-designed study aims to determine whether the use of a device called MIST used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. It will also show whether the MIST regimen improves participants' QoL and reduces the incidence of infection.

The MIST ultrasound system is a non-contact device which delivers low-frequency ultrasound through a gentle saline mist directed at a patient's wound. Patients (over 18 years old) will be invited to take part in this study if they have had a VLU for 6 weeks or more, which measures between 5 and 100 cm^2, and is not infected. Participants with diabetes must show good blood glucose control, and those with underlying chronic disorders which may affect wound healing will be excluded.

All study participants will receive four weeks of standard treatment once a week at a single clinic at the Wound Healing Research Unit (WHRU), University Hospital of Wales. Patients whose wounds reduce by more than 40% during this time will be withdrawn from the study. Remaining patients will be randomly allocated to either the active group or the control group to receive a further eight weeks of treatment. Participants in the active group will receive treatment with the MIST device three times a week, as well as standard care (change of compression bandage and dressings) three times a week. The control group will receive UK standard care (which is dressing and compression bandage change at least once a week). The participants' ulcers will be measured and photographed once a week, and the wound characteristics will be assessed. Changes in participants' health related QoL will be assessed using a questionnaire at the beginning and end of the trial. Wound recurrence rates 90 days after the end of the treatment will be assessed by telephoning patients.

Conditions: Varicose Ulcer
Being tested: MIST ultrasound therapy, Standard Care
Keywords: Venous Leg Ulcer, Varicose Ulcer, Chronic ulcer, Chronic wound, Ultrasound therapy, MIST device, Wound healing, Low frequency non contact ultrasound
Medical subject headings: Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MIST ultrasound therapyDevice
Also called MIST non-contact low-frequecy ultrasound device, MIST
Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.
Standard CareOther
Compression bandaging, non-adherent dressing, and debridement if required.

Study groups in NCT01671748
Study group	Role	What they receive
Standard Care	Active comparator	Standard treatment for VLUs is administered once a week, i.e. compression bandaging and non-adherent dressing, with debridement if required. Receives: Other: Standard Care
MIST and Standard Care	Experimental	MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required. Receives: Device: MIST ultrasound therapy; Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Wound Area
Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.
Measured: Week 5 to 13
Actual Change in Wound Area
Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.
Measured: Week 5 to 13

Secondary outcomes (5)

Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)
On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values.
CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17
Measured: Week 1 (start) and week 13 (exit)
Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)
Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.
Measured: Weeks 5 to 13
Incidence of Wound Infection
Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).
Measured: Weeks 5 to 13
Number of Non-serious Adverse Events in Each Group
Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.
Measured: Week 5 to 13
Wound Recurrence Rate
Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.
Measured: 90 days after time of healing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Dec 2013

First posted24 Aug 2012 (estimated)
Study startAug 2012
Primary completionDec 2013
Study completionDec 2013

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 Varicose UlcerStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01671748
Sponsor's protocol ID: 12-SUR-5323
Status last verified: Jul 2015
First submitted: 21 Aug 2012
Last updated: 26 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Varicose Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Randomised Controlled Trial of MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers.
ClinicalTrials.gov ID: NCT01671748
Acronym / sponsor ID: 12-SUR-5323
Conditions: Varicose Ulcer
Keywords: Venous Leg Ulcer, Varicose Ulcer, Chronic ulcer, Chronic wound, Ultrasound therapy, MIST device, Wound healing, Low frequency non contact ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Cardiff and Vale University Health BoardOther government
Collaborators: Celleration, Inc.
Study start: Aug 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 24 Aug 2012 (estimated)
Results: Posted 26 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Care	Active comparator	Other: Standard CareStandard treatment for VLUs is administered once a week, i.e. compression bandaging and non-adherent dressing, with debridement if required.
MIST and Standard Care	Experimental	Device: MIST ultrasound therapy, Other: Standard CareMIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Venous leg ulcers (as diagnosed by the clinician)
Ankle Brachial Pressure Index (ABPI) >0.8
If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer
18 years or older
Ulcer size of 5 cm^2 - 100 cm^2 (with no longest length being greater than 10 cm) at randomisation point (week 5)

Key exclusion criteria (19 listed)

Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months
Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics
Renal failure
Index ulcer has exposed tendons, ligaments, muscle, or bone
Osteomyelitis or cellulitis or gangrene in study limb

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
MIST ultrasound therapyAlso: MIST non-contact low-frequecy ultrasound device, MISTLow frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.	Device	MIST and Standard Care
Standard CareCompression bandaging, non-adherent dressing, and debridement if required.	Other	MIST and Standard Care, Standard Care

Primary outcome

Percentage Change in Wound Area
Time frame: Week 5 to 13
Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.
Actual Change in Wound Area
Time frame: Week 5 to 13
Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.

5 secondary outcomes

Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)
Time frame: Week 1 (start) and week 13 (exit)
Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)
Time frame: Weeks 5 to 13
Incidence of Wound Infection
Time frame: Weeks 5 to 13
Number of Non-serious Adverse Events in Each Group
Time frame: Week 5 to 13
Wound Recurrence Rate
Time frame: 90 days after time of healing

Results and safety

Results posted to the registry on 26 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	47	36
NLFU and Standard of Care	0	0

Primary outcome: Percentage Change in Wound Area

Time frame: Week 5 to 13. Mean (Standard Deviation). Unit: percentage change in wound area

Measure	Standard of Care n = 19	NLFU and Standard of Care n = 17
Value	-39.2 (38.0)	-46.6 (38.1)

Standard of Care vs NLFU and Standard of Care: Mean Difference (Final Values): -7.4 (95% CI -33.4 to 18.6), p = 0.565, ANCOVA

Population analysed: All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)

Primary outcome: Actual Change in Wound Area

Time frame: Week 5 to 13. Mean (Standard Deviation). Unit: cm2

Measure	Standard of Care n = 19	NLFU and Standard of Care n = 17
Value	-5.3 (5.5)	-6.2 (5.5)

Standard of Care vs NLFU and Standard of Care: Mean Difference (Final Values): -0.9 (95% CI -4.7 to 2.9), p = 0.618, ANCOVA

Population analysed: As previous

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study period of 13 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 19 (0%)	19 of 19 (100%)	Not reported
NLFU and Standard of Care	0 of 17 (0%)	15 of 17 (88.2%)	Not reported

Limitations and caveats (from the sponsor): Difference in treatment frequency between the groups which could potentially bias results. Standard deviation proved to be larger than estimated from the available literature which resulted in the study having reduced statistical power.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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.

Keith G Harding, Professor principal investigator

Wound Healing Research Unit, Cardiff University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MIST ultrasound therapy in people with Varicose Ulcer, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.

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 7 inclusion and 19 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 26 Aug 2015. 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 Kingdom. 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 26 Aug 2015). 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?

Percentage Change in Wound Area (time frame: Week 5 to 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01671748.

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 26 Aug 2015.