Diabetic Foot UlcerNCT04567563
Remote Ischemic Conditioning and Diabetic Foot Ulcers
A study testing Remote Ischemic conditioning (RIC) in people with Diabetic Foot Ulcer and Diabetic Angiopathies, run by Des Moines University.
Trial summary
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC. Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Angiopathies
- What is being tested?
- Remote Ischemic conditioning (RIC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Nov 2022
- 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
- Patient any gender between the ages of 18 and under 90 at the time of consent.
- Target ulcer has a minimum area of 1.0 cm2 and a maximum area of 20.0 cm2, measured at screening after sharp debridement, as assessed by computerized 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 the toe or lateral dorsal, or plantar aspect of the foot with no portion on the ankle.
- Target ulcer is Grade IC (ischemic, non-infected superficial wound) or IIC (ischemic non-infected wound penetrating to tendon or capsule), according to the University of Texas Diabetic Wound Classification system.
- Adequate perfusion without critical limb ischemia, confirmed by vascular assessment of the affected foot through any of the following methods: ABI >0.7
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- Confirmed diagnosis of type 1 or 2 diabetes mellitus
- Patient has a glycated hemoglobin A1c (HbA1c) level of less than 12%
- If patient 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
- Patient is willing to use prescribed off-loading method during the whole duration of the study
- Patient available for the entire study period all follow up visit requirements, and able and willing to adhere to protocol requirements
- Patient able and willing to give written informed consent
Who cannot join
- Target ulcer is less than 1.0 cm2 measured at consent after sharp debridement
- Target ulcer is due to a non-diabetic etiology
- Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection at time of enrollment.
- Presence of any foot ulcer (whether or not on the target foot) for which systemic antibiotic treatment is required.
- A history of more than 8 weeks' treatment with immunosuppressants (including systemic corticosteroids), 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.
- Patients with an amputation on the affected foot, if it impedes proper offloading of the target DFU.
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- Patients 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.
- Patients with concurrent severe psychiatric disease that in the opinion of the investigator would impede participation in the trial.
- Presence of subject having recent or current alcohol or drug abuse.
- Patients with severe kidney disease who are currently untreated or awaiting 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 patient's participation unreliable or may interfere with study assessments.
- Patients with history of radiation to the ulcer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC.
Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot ulcers.
Read more
Randomization and sample size: Subjects will be allocated on a 1:1 ratio, yielding a minimum per protocol population (PP Population) of 15 patients in the Active group and 15 in the control group.
Study timeline: Total amount of time from the Screening Visit to the Final Visit is approximately 16 weeks. For patients who meet inclusion criteria, they are randomized into Active or Control treatment groups. In addition they are stratified into groups based on wound etiology: neuropathic (defined as insensate at 2 or more of 5 sites verified by insensitivity to the 5.07 Semmes-Weinstein 10 g monofilament), ischemic (defined as ABI of 0.7 neuro-ischemic (meeting both of above criteria) Subjects will present at DMU Foot and Ankle Clinic on weeks 0, 3, 6, 9, and 12 for the following measurements: 40mL venous blood draw (VEGF, SDF1a) 2mm punch biopsy (CD34+) Local wound perfusion (Laser Speckle[FK2] ) Ulcer size measured by digital planimetry (TissueAnalytics)
- Conditions
- Diabetic Foot Ulcer, Diabetic Angiopathies
- Being tested
- Remote Ischemic conditioning (RIC)
- Keywords
- remote ischemic conditioning, diabetic foot ulcer, diabetic angiopathy
- Medical subject headings
- Diabetic Foot, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic conditioning (RIC)Device
Intervention Group: Patients will self-administer RIC treatment with the LifeCuff device 3 times a week. Treatment will be delivered at the patient's home and compliance will be monitored by the LifeCuff device. Control Group: Patients undergo typical standard of care treatment. Assessment of Ulcer Closure: Ulcers will be assessed as completely closed by the Principal Investigator through clinical judgement and photographic support. Patients that completely heal their ulcer during the healing period will complete the study and no further blood or tissue measurements will be taken
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Condition | Active comparator | Not described Receives: Device: Remote Ischemic conditioning (RIC) |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ulcer area and overall healing rate
Will evaluate healing rates and times for both treatment group and standard of care group using app that can take picture and measure area
Measured: will be evaluated at 0, 3, 6, 9 and 12 weeks
Secondary outcomes (4)
VEGF
Will evaluate blood levels of VEGF in treatment group and standard of care group
Measured: will be evaluated at 0, 3, 6, 9 and 12 weeks
SDF1a
Will evaluate blood levels of SDF1a in treatment group and standard of care group
Measured: will be evaluated at 0, 3, 6, 9 and 12 weeks
CD34+
Will evaluate soft tissue biopsy for presence or absence of CD34+ in treatment group and standard of care group
Measured: will be evaluated at 0, 3, 6, 9 and 12 weeks
tissue perfusion
Will evaluate overall tissue perfusion using Laser Speckle imaging for both treatment group and standard of care group
Measured: will be evaluated at 0, 3, 6, 9 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 posted28 Sep 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
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
- Will have intervention group and standard of care group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa State University
- Responsible party
- Principal investigator, Katherine Frush, Des Moines University
- Investigators
- Katherine Frush, DPM, Principal investigator, Des Moines University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567563
- Sponsor's protocol ID
- IRB-2020-3
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04567563
- Acronym / sponsor ID
- IRB-2020-3
- Conditions
- Diabetic Foot Ulcer, Diabetic Angiopathies
- Keywords
- remote ischemic conditioning, diabetic foot ulcer, diabetic angiopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Collaborators
- Iowa State University
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Sep 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.
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC.
Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot ulcers.
Randomization and sample size: Subjects will be allocated on a 1:1 ratio, yielding a minimum per protocol population (PP Population) of 15 patients in the Active group and 15 in the control group.
Study timeline: Total amount of time from the Screening Visit to the Final Visit is approximately 16 weeks. For patients who meet inclusion criteria, they are randomized into Active or Control treatment groups. In addition they are stratified into groups based on wound etiology: neuropathic (defined as insensate at 2 or more of 5 sites verified by insensitivity to the 5.07 Semmes-Weinstein 10 g monofilament), ischemic (defined as ABI of 0.7 neuro-ischemic (meeting both of above criteria) Subjects will present at DMU Foot and Ankle Clinic on weeks 0, 3, 6, 9, and 12 for the following measurements: 40mL venous blood draw (VEGF, SDF1a) 2mm punch biopsy (CD34+) Local wound perfusion (Laser Speckle[FK2] ) Ulcer size measured by digital planimetry (TissueAnalytics)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Will have intervention group and standard of care group
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Condition | Active comparator | Device: Remote Ischemic conditioning (RIC) |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient any gender between the ages of 18 and under 90 at the time of consent.
- Target ulcer has a minimum area of 1.0 cm2 and a maximum area of 20.0 cm2, measured at screening after sharp debridement, as assessed by computerized 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 the toe or lateral dorsal, or plantar aspect of the foot with no portion on the ankle.
- Target ulcer is Grade IC (ischemic, non-infected superficial wound) or IIC (ischemic non-infected wound penetrating to tendon or capsule), according to the University of Texas Diabetic Wound Classification system.
Key exclusion criteria (14 listed)
- Target ulcer is less than 1.0 cm2 measured at consent after sharp debridement
- Target ulcer is due to a non-diabetic etiology
- Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection at time of enrollment.
- Presence of any foot ulcer (whether or not on the target foot) for which systemic antibiotic treatment is required.
- A history of more than 8 weeks' treatment with immunosuppressants (including systemic corticosteroids), 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.
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)Intervention Group: Patients will self-administer RIC treatment with the LifeCuff device 3 times a week. Treatment will be delivered at the patient's home and compliance will be monitored by the LifeCuff device. Control Group: Patients undergo typical standard of care treatment. Assessment of Ulcer Closure: Ulcers will be assessed as completely closed by the Principal Investigator through clinical judgement and photographic support. Patients that completely heal their ulcer during the healing period will complete the study and no further blood or tissue measurements will be taken | Device | Remote Ischemic Condition |
Primary outcome
Change in ulcer area and overall healing rate
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
Will evaluate healing rates and times for both treatment group and standard of care group using app that can take picture and measure area
4 secondary outcomes
VEGF
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
SDF1a
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
CD34+
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
tissue perfusion
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Katherine Frush, DPM principal investigator
Des Moines University
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic conditioning (RIC) in people with Diabetic Foot Ulcer and Diabetic Angiopathies, run by Des Moines University.
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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Frush, DPM (515-271-1731, katherine.frush@dmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ulcer area and overall healing rate (time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks). 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 28 Sep 2020.