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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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

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

Other trials in Pakistan

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

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 groups in NCT07763795
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.

17 Apr 20251 Nov 2026

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.
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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Not yet recruiting
Activity Reduction vs Advice for Plantar Hotspots in Diabetes
Diabetic Foot, Diabetic Peripheral Neuropathy
Active, not recruiting
" Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."
Balance Impairment in Peripheral Diabetic Neuropathy
RecruitingPhase 2
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Painful Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain (DPN)

All Diabetic Neuropathy Peripheral trials