Diabetic Foot UlcerPhase 4NCT01608776
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
A Phase 4 study testing MIST Therapy in people with Diabetic Foot Ulcer, run by Celleration, Inc. at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- 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
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 and at least 18 to 90 years old
- Lower extremity full thickness diabetic foot ulcer of 30-364 days duration
- Subject's wound must be between 2cm² and 20cm² at screening
- Subject's wound must be at or below the malleolus
- Documented ABI is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) within 30 days of screening.
- Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
- Subject is willing and able to comply with all specified care and visit requirements
- Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.
Who cannot join
- Index ulcer wound has exposed tendons, ligaments, muscle, or bone
- Index ulcer wound presents with clinical signs of acute infection, suspected or known
- Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
- Subjects with active Charcot's foot on the study limb
- Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the affected limb
- Subjects with active malignancy on the study limb except non-melanoma skin cancer
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- Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study period
- Subjects within 6 weeks post-operatively of a vascular procedure.
- Subject has had prior skin replacement, negative pressure therapy, or ultrasound therapy applied to the index wound in the 14 days prior to screening
- Subjects who have received oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
- Subjects who have received topical antibiotic/antimicrobial agents or dressings at the index wound site within 2 days (48 hours) of baseline.
- Subjects currently taking steroids of >10mg dosage
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Subject has one or more medical condition(s), uncontrolled diabetes (HbA1c > 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate
- Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
- 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 investigational device or drug trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- MIST Therapy, SOC - Standard of Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
The MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds.
SOC - Standard of CareOther
Standard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading
| Study group | Role | What they receive |
|---|---|---|
| SOC - Standard of Care | Active comparator | Wound cleansing and debridement as needed, moist wound healing dressing, and off-loading Receives: Other: SOC - Standard of Care |
| SOC + MIST Therapy | Active comparator | Wound cleansing and debridement as needed, moist wound healing dressing, off-loading, and MIST treatment Receives: Device: MIST Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Reduction
Compare between the treatment groups the index wound area percent reduction, calculated as the difference in cm2 of the randomization measurement to the post four weeks of study treatment measurement.
Measured: 12 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionMar 2013
Why it stopped: Enrollment delays, business re-allocation of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vickie Driver, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608776
- Sponsor's protocol ID
- CR-86036
- Status last verified
- Oct 2014
- First submitted
- 29 May 2012
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
- ClinicalTrials.gov ID
- NCT01608776
- Acronym / sponsor ID
- CR-86036
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment delays, business re-allocation of resources
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
Study design
- Primary purpose
- Treatment
- 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: SOC - Standard of CareWound cleansing and debridement as needed, moist wound healing dressing, and off-loading |
| SOC + MIST Therapy | Active comparator | Device: MIST TherapyWound cleansing and debridement as needed, moist wound healing dressing, off-loading, and MIST treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject of any race and at least 18 to 90 years old
- Lower extremity full thickness diabetic foot ulcer of 30-364 days duration
- Subject's wound must be between 2cm² and 20cm² at screening
- Subject's wound must be at or below the malleolus
- Documented ABI is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) within 30 days of screening.
Key exclusion criteria (19 listed)
- Index ulcer wound has exposed tendons, ligaments, muscle, or bone
- Index ulcer wound presents with clinical signs of acute infection, suspected or known
- Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb
- Subjects with active Charcot's foot on the study limb
- Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the affected 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 TherapyThe MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds. | Device | SOC + MIST Therapy |
| SOC - Standard of CareStandard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading | Other | SOC - Standard of Care |
Primary outcome
Wound Reduction
Time frame: 12 weeks post randomization
Compare between the treatment groups the index wound area percent reduction, calculated as the difference in cm2 of the randomization measurement to the post four weeks of study treatment measurement.
Results and safety
The study was stopped early (reason given: Enrollment delays, business re-allocation of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Vickie Driver, DPM principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIST Therapy in people with Diabetic Foot Ulcer, 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 8 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: stopped early, as of the sponsor's last update on 8 Oct 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment delays, business re-allocation of resources). Results are not available in the source record.
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?
Wound Reduction (time frame: 12 weeks post randomization). 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 8 Oct 2014.