Wound of SkinNCT01540981
Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study
A study testing MIST Therapy in people with Wound of Skin, run by Celleration, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound of Skin
- What is being tested?
- MIST Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject of any race 18-90 years old.
- Subject presents with an index DTI. This is defined by the National Pressure Ulcer Advisory Panel (NPUAP) as a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
- Subject's DTI has been discovered ≤ 72 hours after causative event
- Causative event of DTI is identified.
- Subject's index DTI is located on torso or body extremities.
- Subject is currently admitted to the hospital.
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- Subject is able to be maneuvered into a position that is acceptable for MIST treatment.
- Subject's DTI presents with no clinical signs of acute infection.
- Subject or subject's legally authorized representative understands the nature of the procedures and provides written informed consent prior to study enrollment.
Who cannot join
- Subject's primary wound is a Stage I, Stage II, Stage III or Stage IV pressure ulcer.
- Subject's wound presents with a malignancy in the wound bed.
- Subject has a history of pressure ulcer / DTI in same location.
- Subject's DTI would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker.
- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
- Subject is terminally ill, defined as unable to survive beyond 14 days.
- Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements.
- Subject is currently enrolled or has been enrolled in the last 30 days in another device or drug trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury
The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.
Read the detailed description
Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with Standard of Care (MIST + SOC) (treatment group) or b) SOC only (control group).
A randomized subject will be required to undergo a Baseline Evaluation. The Baseline Evaluation. A digital photo will be taken of the wound.
The subject will receive the assigned study treatment. Each subject will receive SOC wound care and off-loading daily throughout the study. Subjects will be treated daily for 5 days and then every other day until discharged or up to 14 days post enrollment.
- Conditions
- Wound of Skin
- Being tested
- MIST Therapy, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
Also called MIST Therapy, MIST, Non-Contact Ultrasound
FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
Standard of CareOther
Standard of Care consists of pressure relief, wound cleansing and dressing as needed
| Study group | Role | What they receive |
|---|---|---|
| SOC - Standard of Care | Active comparator | Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Receives: Other: Standard of Care |
| MIST Therapy with SOC | Active comparator | Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days Receives: Device: MIST Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue).
Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy
Measured: 14 days
Secondary outcomes (1)
Change in Mean Wound Area
Measured from randomization to last visit (14 days or at discharge from hospital)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJul 2013
Why it stopped: Lack of enrollment
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 Wound of SkinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Black, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540981
- Sponsor's protocol ID
- CR-86034
- Status last verified
- Jan 2015
- First submitted
- 20 Feb 2012
- Last updated
- 15 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of the Effects of MIST Therapy on the Treatment of Deep Tissue Injury
- ClinicalTrials.gov ID
- NCT01540981
- Acronym / sponsor ID
- CR-86034
- Conditions
- Wound of Skin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.
Detailed description
Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with Standard of Care (MIST + SOC) (treatment group) or b) SOC only (control group).
A randomized subject will be required to undergo a Baseline Evaluation. The Baseline Evaluation. A digital photo will be taken of the wound.
The subject will receive the assigned study treatment. Each subject will receive SOC wound care and off-loading daily throughout the study. Subjects will be treated daily for 5 days and then every other day until discharged or up to 14 days post enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC - Standard of Care | Active comparator | Other: Standard of CareStandard of care consists of pressure relief, creams, wound cleansing and dressings as needed |
| MIST Therapy with SOC | Active comparator | Device: MIST TherapyStandard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject of any race 18-90 years old.
- Subject presents with an index DTI. This is defined by the National Pressure Ulcer Advisory Panel (NPUAP) as a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
- Subject's DTI has been discovered ≤ 72 hours after causative event
- Causative event of DTI is identified.
- Subject's index DTI is located on torso or body extremities.
Key exclusion criteria (8 listed)
- Subject's primary wound is a Stage I, Stage II, Stage III or Stage IV pressure ulcer.
- Subject's wound presents with a malignancy in the wound bed.
- Subject has a history of pressure ulcer / DTI in same location.
- Subject's DTI would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker.
- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
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 TherapyAlso: MIST Therapy, MIST, Non-Contact UltrasoundFDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area. | Device | MIST Therapy with SOC |
| Standard of CareStandard of Care consists of pressure relief, wound cleansing and dressing as needed | Other | SOC - Standard of Care |
Primary outcome
Effectiveness
Time frame: 14 days
To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue). Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy
1 secondary outcome
Change in Mean Wound Area
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 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.
Joyce Black, PhD, RN principal investigator
University of Nebraska
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 Therapy in people with Wound of Skin, run by Celleration, Inc. 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Jan 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 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 15 Dec 2014). 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?
Effectiveness (time frame: 14 days). 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 15 Jan 2015.