Diabetic Neuropathy PeripheralNCT07763795
Effects of BFRT on Glycemic Control, Nerve Conduction, Functional Outcomes and QOL in Individuals With Type 2 Diabetes
A study testing BFR with low resistance high repetition exercises and low resistance high repetition exercises in people with Diabetic Neuropathy Peripheral, run by Superior University at 1 site in Pakistan.
Trial summary
Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- BFR with low resistance high repetition exercises and low resistance high repetition exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes (≥5 years) patients diagnosed
- random blood glucose ≥ 11.1mmol/L;
- fasting blood glucose ≥ 7.0 mmol/L
- Haemoglobin A1c 6.5%-9.5%. 2) Can walk independently, no severe joint limitations
- Can safely perform resistance training
- Stable diabetic \& neuropathy meds for 3+ months
Who cannot join
- suffers frequent hypoglycaemia,
- severe diabetes complications
- Diagnosed cases of neuromuscular disorders
- history of stroke/DVT
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sahiwal Diabetes and Foor care Clinic
Sahiwal, Punjab Province
About this study
Official title: Effects of Blood Flow Restriction Training on Glycemic Control, Nerve Conduction, Functional Outcomes and Quality of Life in Individuals With Type 2 Diabetes Peripheral Neuropathy
Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis.
Read the detailed description
The objective of this study will be to determine the effect of Blood flow restriction training on peripheral neuropathy in diabetes II patients. The study will be randomized controlled trial. Sample size will be determined by pilot study.
The single blinding will be applied. Randomization will be done by lottery method.
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- BFR with low resistance high repetition exercises, low resistance high repetition exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR with low resistance high repetition exercisesCombination product
Three set(30,15,15) with 20% of 1RM(repetition maximum) along with BFR (40% LOP). Rest between sets 60s
low resistance high repetition exercisesCombination product
Three set(30,15,15) with 20% of 1RM(repetition maximum)
| Study group | Role | What they receive |
|---|---|---|
| BFR with low resistance high repetition exercises | Experimental | Not described Receives: Combination Product: BFR with low resistance high repetition exercises |
| low resistance high repetition exercises | Active comparator | Not described Receives: Combination Product: low resistance high repetition exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
HbA1c reflects the average blood glucose concentration over the 3 months by measuring the percentage of hemoglobin that is glycated.
Scoring is as following: below 5.7% being normal, 5.7%-6.4% prediabetes, and 6.5% higher diabetes
Measured: 12 Months
Nerve Conduction Velocity
Nerve conduction velocity measures the speed at which an electrical impulse travels along a peripheral nerve and is used to assess the functional integrity of peripheral nerves. It is particularly useful for detecting and quantifying peripheral nerve dysfunction in diabetic neuropathy.
Scoring:
NCV is recorded in m/s; typical adult lower reference limits are approximately ≥40-45 m/s for lower-limb motor nerves and ≥40-50 m/s for sensory nerves, with values below the laboratory-specific reference range considered abnormal.
Measured: 12 Months
Numeric pain rating scale (NPRS)
It is used to assess pain intensity
Scoring is as following :
its 11-point scale (0-10) 0 means "no pain" and 10 represents "worst possible pain."
Measured: 12 Months
The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument
The Norfolk QOL-DN measures the impact of diabetic neuropathy on overall health-related quality of life Scoring is as following :Total score of tool is 160. 0-40 score mean Mild or no impairment,41-80 score mean Moderate impairment and 81-160 mean Severe impact on quality of life.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start17 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763795
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2230
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training on Glycemic Control, Nerve Conduction, Functional Outcomes and Quality of Life in Individuals With Type 2 Diabetes Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07763795
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2230
- Conditions
- Diabetic Neuropathy Peripheral
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Aug 2026 (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.
Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis.
Detailed description
The objective of this study will be to determine the effect of Blood flow restriction training on peripheral neuropathy in diabetes II patients. The study will be randomized controlled trial. Sample size will be determined by pilot study.
The single blinding will be applied. Randomization will be done by lottery method.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR with low resistance high repetition exercises | Experimental | Combination Product: BFR with low resistance high repetition exercises |
| low resistance high repetition exercises | Active comparator | Combination Product: low resistance high repetition exercises |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes (≥5 years) patients diagnosed
- random blood glucose ≥ 11.1mmol/L;
- fasting blood glucose ≥ 7.0 mmol/L
- Haemoglobin A1c 6.5%-9.5%. 2) Can walk independently, no severe joint limitations
- Can safely perform resistance training
Key exclusion criteria (4 listed)
- suffers frequent hypoglycaemia,
- severe diabetes complications
- Diagnosed cases of neuromuscular disorders
- history of stroke/DVT
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 |
|---|---|---|
| BFR with low resistance high repetition exercisesThree set(30,15,15) with 20% of 1RM(repetition maximum) along with BFR (40% LOP). Rest between sets 60s | Combination product | BFR with low resistance high repetition exercises |
| low resistance high repetition exercisesThree set(30,15,15) with 20% of 1RM(repetition maximum) | Combination product | low resistance high repetition exercises |
Primary outcome
Glycated Hemoglobin
Time frame: 12 Months
HbA1c reflects the average blood glucose concentration over the 3 months by measuring the percentage of hemoglobin that is glycated. Scoring is as following: below 5.7% being normal, 5.7%-6.4% prediabetes, and 6.5% higher diabetes
Nerve Conduction Velocity
Time frame: 12 Months
Nerve conduction velocity measures the speed at which an electrical impulse travels along a peripheral nerve and is used to assess the functional integrity of peripheral nerves. It is particularly useful for detecting and quantifying peripheral nerve dysfunction in diabetic neuropathy. Scoring: NCV is recorded in m/s; typical adult lower reference limits are approximately ≥40-45 m/s for lower-limb motor nerves and ≥40-50 m/s for sensory nerves, with values below the laboratory-specific reference range considered abnormal.
Numeric pain rating scale (NPRS)
Time frame: 12 Months
It is used to assess pain intensity Scoring is as following : its 11-point scale (0-10) 0 means "no pain" and 10 represents "worst possible pain."
The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument
Time frame: 12 Months
The Norfolk QOL-DN measures the impact of diabetic neuropathy on overall health-related quality of life Scoring is as following :Total score of tool is 160. 0-40 score mean Mild or no impairment,41-80 score mean Moderate impairment and 81-160 mean Severe impact on quality of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR with low resistance high repetition exercises and low resistance high repetition exercises in people with Diabetic Neuropathy Peripheral, run by Superior University at 1 site in Pakistan.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Glycated Hemoglobin (time frame: 12 Months). The study lists 4 primary outcomes in all. 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 13 Aug 2026.