Diabetic Foot UlcerNCT04332003
Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care
A study testing Remote Ischemic Conditioning (RIC) Treatment in people with Diabetic Foot Ulcer, run by SerenaGroup, Inc..
Trial summary
A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care. 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?
- Remote Ischemic Conditioning (RIC) Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 6 Feb 2021
- Phase
- Interventional
- 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
- Subjects of any gender between the ages of 18 and under 90 at the time of consent. The goal will be to enroll 50% of the subjects who are Medicare beneficiaries.
- Target ulcer has a minimum area of 0.7 cm2 and a maximum area of 20.0 cm2, measured at randomization after sharp debridement, as assessed by photographic planimetry.
- Target ulcer open for a minimum of 4 weeks and a maximum of 52 weeks duration prior to the screening visit.
- Target ulcer is located on any aspect of the foot, including the toe, lateral dorsal, medial or plantar aspect of the foot. At least 50% of the ulcer must be below the malleolus.
- Target ulcer is Wagner Grade I or Grade II without exposed bone.
- Subjects' wound score on IDSA tool is Grade 1 or 2.
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- Adequate perfusion without critical limb ischemia, confirmed by vascular assessment of the affected foot through any of the following methods within 3 months of the first screening visit:
- Toe pressure ≥ 50 mm Hg; Ankle pressure ≥70 mm Hg; ABI between 0.7 and ≤ 1.3; TCOM ≥ 40 mmHg; Doppler ultrasound scan of peripheral blood flow with wave patterns that are triphasic or biphasic; Skin Perfusion Pressure (SPP) ≥30 mmHg.
- Diagnosis of type 1 or 2 Diabetes mellitus,
- Subject has a known glycated hemoglobin A1c (HbA1c) level of less than 12% within the last three months.
- If subject has two or more ulcers, they must be separated by at least 2 cm and the largest one will be included as the study DFU though all will be similarly treated.
- The target ulcer has been offloaded for at least 14 days prior to randomization.
- Subject is willing to use prescribed off-loading method for the duration of the study.
- Subject is available for the entire study period and all follow up visits. In addition, the subject is able and willing to adhere to the protocol requirements.
- Subject able and willing to give written informed consent.
Who cannot join
- Target ulcer is due to a non-diabetic etiology.
- Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.
- If the Target ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV-0/randomization visit.
- An ulcer that has healed by more than 20% in the 2 weeks prior to screening: "historical" run-in period.
- Presence of any foot ulcer (whether or not on the target foot) for which local or systemic antibiotic treatment is required.
- A history of more than 8 weeks' treatment with immunosuppressants (including systemic corticosteroids at doses greater than 5mg of Prednisone or equivalent), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or treatments with such medications during the screening period, or anticipated requirement of such medications during the study.
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- Subjects with an amputation on the affected foot, only if it impedes proper offloading of the target DFU.
- Subjects with active Charcot foot, or inactive Charcot foot, if it impedes proper offloading of the target DFU.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- Presence of subject having recent or current alcohol or drug abuse.
- Subjects with severe kidney disease who are currently untreated or undergoing dialysis treatment.
- Participation in another study involving treatment with an investigational product within the previous 30 days.
- Any other medical or psychological conditions that, in the opinion of the Investigator, may make subject's participation unreliable or may interfere with study assessments.
- There is a history of radiation to the target ulcer.
- Subject has received HBO less than 30 days prior to screening.
- Subject has received a cellular tissue product (CTP) less than 30 days prior to screening.
About this study
Official title: A Randomized Controlled Double-Blind Multi-Center Clinical Trial Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care in the Healing of Diabetic Foot Ulcers
A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care.
Read the detailed description
The general objective of this double-blind study is to test the effectiveness of RIC in a population of patients with diabetic foot ulcers: Active treatment 3x per week (RIC) plus SOC compared to Sham Comparator 3x per week and SOC
Determine median time to initial wound closure in both active and sham group.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Remote Ischemic Conditioning (RIC) Treatment
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning (RIC) TreatmentDevice
RIC treatment will be delivered by an automated device that delivers the RIC treatment (manufactured by LifeCuff Technologies).
| Study group | Role | What they receive |
|---|---|---|
| RIC Treatment | Active comparator | Participants will receive active RIC treatment 3 times per week over the course of the study. Each session will last approximately 45 minutes Receives: Device: Remote Ischemic Conditioning (RIC) Treatment |
| SHAM Comparator | No intervention | Participants will receive sham treatment 3 times per week over the course of the study. Each session will last approximately 45 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound closure.
Specifically, to determine the median time to initial wound closure in both the active treatment group and the sham treatment group
Measured: 12-18 months
Secondary outcomes (11)
Percentage of target wounds achieving closure
The proportion of wounds that heal in a 12-week period
Measured: 12-week healing period
Percentage wound area reduction from TV-0 per week measured with digital planimetry and physical examination
The percentage of reduction in wound area from baseline
Measured: 12- week
Change in DFU maximum depth in mm assessed by the Principal Investigator and documented by computer planimetry
The change in depth in mm over from baseline
Measured: 12 week
Change in score of each domain on the CWIQ (Cardiff Wound Impact Questionnaire)
Assess the change in daily quality of life
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in pain regarding to the ulcer assessed using PEG (Pain, Enjoyment and General Activity) Scale
Assess change in pain level
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
The percentage of time offloaded
Offloading compliance with a prescribed offloading boot.
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in skin sensitivity on the foot
Assess change in skin sensitivity on the foot tested by performing standardized monofilament test over a standardized set of points on the foot
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Percentage of time wearing the boot
Compliance with a prescribed offloading boot
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in Foot Infection
Change in Foot Infection measured by the IDSA (Infectious Diseases Society of America) infection scale
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in Wound Drainage
Qualitatively assess the change in amount of drainage (low, moderate, heavy)
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in oxygenation at the wound site
Assess change in oxygenation at the wound site using Near Infrared Reflectance Oximetry in a sub-group of subjects
Measured: Day 0, 3 weeks, 6 weeks, 9 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jan 2021 (estimated)
- Primary completion6 Feb 2021
- Study completion6 Feb 2021
Why it stopped: Sponsor
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- LifeCuff device includes a controller attached to a standard inflatable cuff used for blood pressure measurements.The controller includes a controller electronics board connected to a pneumatic assembly designed to automatically inflate and deflate the cuff to desired air pressures while monitoring and analyzing the oscillometric pulsations modulating the cuff pressure as captured by the system's pressure transducer. LifeCuff can be battery-powered or connected by an adaptor to a house electrical outlet.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- LifeCuff Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD,FACS, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332003
- Sponsor's protocol ID
- LC-RIC
- Status last verified
- Feb 2021
- First submitted
- 30 Mar 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-Blind Multi-Center Clinical Trial Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care in the Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04332003
- Acronym / sponsor ID
- LC-RIC
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- LifeCuff Technologies Inc.
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- 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.
A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care.
Detailed description
The general objective of this double-blind study is to test the effectiveness of RIC in a population of patients with diabetic foot ulcers: Active treatment 3x per week (RIC) plus SOC compared to Sham Comparator 3x per week and SOC
Determine median time to initial wound closure in both active and sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- LifeCuff device includes a controller attached to a standard inflatable cuff used for blood pressure measurements.The controller includes a controller electronics board connected to a pneumatic assembly designed to automatically inflate and deflate the cuff to desired air pressures while monitoring and analyzing the oscillometric pulsations modulating the cuff pressure as captured by the system's pressure transducer. LifeCuff can be battery-powered or connected by an adaptor to a house electrical outlet.
| Arm | Type | Receives |
|---|---|---|
| RIC Treatment | Active comparator | Device: Remote Ischemic Conditioning (RIC) TreatmentParticipants will receive active RIC treatment 3 times per week over the course of the study. Each session will last approximately 45 minutes |
| SHAM Comparator | No intervention | –Participants will receive sham treatment 3 times per week over the course of the study. Each session will last approximately 45 minutes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects of any gender between the ages of 18 and under 90 at the time of consent. The goal will be to enroll 50% of the subjects who are Medicare beneficiaries.
- Target ulcer has a minimum area of 0.7 cm2 and a maximum area of 20.0 cm2, measured at randomization after sharp debridement, as assessed by photographic planimetry.
- Target ulcer open for a minimum of 4 weeks and a maximum of 52 weeks duration prior to the screening visit.
- Target ulcer is located on any aspect of the foot, including the toe, lateral dorsal, medial or plantar aspect of the foot. At least 50% of the ulcer must be below the malleolus.
- Target ulcer is Wagner Grade I or Grade II without exposed bone.
Key exclusion criteria (16 listed)
- Target ulcer is due to a non-diabetic etiology.
- Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.
- If the Target ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV-0/randomization visit.
- An ulcer that has healed by more than 20% in the 2 weeks prior to screening: "historical" run-in period.
- Presence of any foot ulcer (whether or not on the target foot) for which local or systemic antibiotic treatment is required.
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 |
|---|---|---|
| Remote Ischemic Conditioning (RIC) TreatmentRIC treatment will be delivered by an automated device that delivers the RIC treatment (manufactured by LifeCuff Technologies). | Device | RIC Treatment |
Primary outcome
Time to complete wound closure.
Time frame: 12-18 months
Specifically, to determine the median time to initial wound closure in both the active treatment group and the sham treatment group
11 secondary outcomes
Percentage of target wounds achieving closure
Time frame: 12-week healing period
Percentage wound area reduction from TV-0 per week measured with digital planimetry and physical examination
Time frame: 12- week
Change in DFU maximum depth in mm assessed by the Principal Investigator and documented by computer planimetry
Time frame: 12 week
Change in score of each domain on the CWIQ (Cardiff Wound Impact Questionnaire)
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in pain regarding to the ulcer assessed using PEG (Pain, Enjoyment and General Activity) Scale
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
The percentage of time offloaded
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in skin sensitivity on the foot
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Percentage of time wearing the boot
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in Foot Infection
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in Wound Drainage
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks, and 12 weeks
Change in oxygenation at the wound site
Time frame: Day 0, 3 weeks, 6 weeks, 9 weeks and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Thomas E Serena, MD,FACS principal investigator
SerenaGroup, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning (RIC) Treatment in people with Diabetic Foot Ulcer, run by SerenaGroup, Inc..
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 15 inclusion and 16 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: withdrawn, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to complete wound closure. (time frame: 12-18 months). 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 Feb 2021.