Diabetic Peripheral NeuropathyEIHDMNCT05296642
Exercise Induced Hypoalgesia Diabetes
A study testing Moderate Cycling and Personalized Tourniquet System in people with Diabetic Peripheral Neuropathy and Diabetic Peripheral Neuropathic Pain, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Moderate Cycling and Personalized Tourniquet System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Aug 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the ages of 18 - 65.
- Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose > 126 mg/dL, or an oral glucose tolerance test > 200 mg/dL.
- Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
- Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
- Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.
Who cannot join
- Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
- Subjects with current or history of central nervous system disorders.
- Subjects with resting hypertension (HTN) >/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
- Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
- Subjects with Reynaud's disease or cold urticaria.
- All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Exploring the Use of Blood Flow Restriction in Addition to Aerobic Exercise as a Modality to Produce Exercise Induced Hypoalgesia in Participants With Painful Diabetic Peripheral Neuropathy.
The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.
- Being tested
- Moderate Cycling, Personalized Tourniquet System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate CyclingOther
Using the recumbent bicycle (95Ri, Life Fitness, Illinois) participants will be asked to sustain a moderate pace of 13 - 16 for 20 minutes of perceived exertion range using the Borg rate of perceived exertion scale (RPE).
Personalized Tourniquet SystemOther
An automated personalize tourniquet system (Delfi Medical, Inc., Vancouver, BC, Canada) will be used to perform blood flow restriction during BFR+AE. This system has a dual-purpose tourniquet cuff (11.5 x 86 cm) connected by airtight hose tubing to a personalized tourniquet device. The device automatically measures LOP and regulated pressure during exercise within clinically acceptable limits. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Following, a tourniquet cuff will be placed bilaterally around the protection material and connected to the airtight hose tube.
| Study group | Role | What they receive |
|---|---|---|
| Cycling at a Moderate Intensity Aerobic Exercise (AE) group | Experimental | All participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes. Receives: Other: Moderate Cycling |
| Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group | Experimental | All participants will be asked to wear an automated personalize tourniquet system to restrict blood flow. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Then, participants will be asked to cycle at a moderate intensity for 20 minutes during the second phase. Receives: Other: Moderate Cycling; Other: Personalized Tourniquet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Pressure Threshold (PPT)
PPT will be measured both locally at the quadriceps and distally at the upper trapezius. The PPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in PPT (PPT following exercise subtracted from PPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.
Measured: Baseline, 20 minutes
Secondary outcomes (1)
Change in Heat Pain Threshold (HPT)
HPT will be measured both locally at the quadriceps and distally at the upper trapezius. The HPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in HPT (HPT following exercise subtracted from HPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.
Measured: Baseline, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Why it stopped: Principal investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Wong, University of Miami
- Investigators
- Marlon L. Wong, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296642
- Sponsor's protocol ID
- 20220189
- Acronym
- EIHDM
- Status last verified
- May 2022
- First submitted
- 16 Mar 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Blood Flow Restriction in Addition to Aerobic Exercise as a Modality to Produce Exercise Induced Hypoalgesia in Participants With Painful Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT05296642
- Acronym / sponsor ID
- EIHDM / 20220189
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 25 Mar 2022 (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.
The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling at a Moderate Intensity Aerobic Exercise (AE) group | Experimental | Other: Moderate CyclingAll participants will be asked to cycle during the first phase at a moderate intensity for 20 minutes. |
| Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group | Experimental | Other: Moderate Cycling, Other: Personalized Tourniquet SystemAll participants will be asked to wear an automated personalize tourniquet system to restrict blood flow. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Then, participants will be asked to cycle at a moderate intensity for 20 minutes during the second phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects between the ages of 18 - 65.
- Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose > 126 mg/dL, or an oral glucose tolerance test > 200 mg/dL.
- Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
- Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
- Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.
Key exclusion criteria (6 listed)
- Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
- Subjects with current or history of central nervous system disorders.
- Subjects with resting hypertension (HTN) >/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
- Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
- Subjects with Reynaud's disease or cold urticaria.
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 |
|---|---|---|
| Moderate CyclingUsing the recumbent bicycle (95Ri, Life Fitness, Illinois) participants will be asked to sustain a moderate pace of 13 - 16 for 20 minutes of perceived exertion range using the Borg rate of perceived exertion scale (RPE). | Other | Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group, Cycling at a Moderate Intensity Aerobic Exercise (AE) group |
| Personalized Tourniquet SystemAn automated personalize tourniquet system (Delfi Medical, Inc., Vancouver, BC, Canada) will be used to perform blood flow restriction during BFR+AE. This system has a dual-purpose tourniquet cuff (11.5 x 86 cm) connected by airtight hose tubing to a personalized tourniquet device. The device automatically measures LOP and regulated pressure during exercise within clinically acceptable limits. Participants will be asked to lie in supine and a non-shedding stockinette protection sleeve will be placed at bilateral proximal thighs. Following, a tourniquet cuff will be placed bilaterally around the protection material and connected to the airtight hose tube. | Other | Blood Flow restriction training with cycling at a moderate intensity (BFR+AE) group |
Primary outcome
Change in Pain Pressure Threshold (PPT)
Time frame: Baseline, 20 minutes
PPT will be measured both locally at the quadriceps and distally at the upper trapezius. The PPT will be determined with three series of ascending stimulus intensities at each point over 3 rounds. A positive change in PPT (PPT following exercise subtracted from PPT before exercise) will demonstrate an intact exercise induced hypoalgesic response.
1 secondary outcome
Change in Heat Pain Threshold (HPT)
Time frame: Baseline, 20 minutes
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 25 May 2022.
- 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.
Marlon L. Wong, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Cycling and Personalized Tourniquet System in people with Diabetic Peripheral Neuropathy and Diabetic Peripheral Neuropathic Pain, run by University of Miami 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 5 inclusion and 6 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 25 May 2022. 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?
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?
Change in Pain Pressure Threshold (PPT) (time frame: Baseline, 20 minutes). 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 25 May 2022.