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Diabetic FootNCT07841730

Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer

A study testing Tibial Nerve Mobilization and Multisensory exercises in people with Diabetic Foot, run by University of Lahore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Diabetic Foot
What is being tested?
Tibial Nerve Mobilization and Multisensory exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
Sep 2026to May 2027
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 55-75 years
  • Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
  • Both male and female participants.
  • Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
  • Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
  • Patient with healed ulcer or in last stage of healing duration >1 to 2 weeks
Show all 11Show fewer
  • Absence of active infection.
  • No cognitive impairments that would affect participation.
  • Diabetes duration of less than 10 years.
  • Able to perform the exercises and participate in physical therapy sessions.
  • No history of amputation above the metatarsophalangeal joint.

Who cannot join

  • Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
  • Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
  • Recent fractures, or trauma leading to nerve injuries in the last year.
  • Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
  • Visual impairments or cognitive disorders that could affect participation.
  • History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
  • Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
  • Pregnancy or unwillingness to participate.

About this study

The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.

Conditions
Diabetic Foot
Being tested
Tibial Nerve Mobilization, Multisensory exercises
Keywords
Tibial nerve mobilization, Multisensory Exercises, Diabetic foot ulcer, Diabetic Peripheral neuropathy
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tibial Nerve MobilizationBehavioural

    Also called Nerve flossing, Neural Mobilization, Neural Gliding

    Participants will receive supervised physical therapy targeting neuropathic symptoms, healing , mobility issues, quality of life associated with diabetic foot ulcers early grades. The regimen consists of 35 to 45 -minute sessions, 3 days per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy, including Transcutaneous Electrical Nerve Stimulation (TENS).Pulse Duration: 150 µs and 80 Hz frequency for effective nerve stimulation and pain relief, active and passive ankle range-of-motion exercises, dosriflexion and plantar flexion, inversion eversion ,with 10 repetitions for10 minutes and foot care education which includes moisturizing and hygiene advice and foot wear guidance . This is followed by a 20-minute main intervention of tibial nerve mobilization, which utilizes a combination of remote sliders, local sliders, and tensioners (end-range neural loading) to promote neural sliding and elongation while minimizing mechanical stress.

  • Multisensory exercisesBehavioural

    Participants will receive a multisensory exercises training program alongside conventional physical therapy. The regimen consists of 35-to 45 minute sessions, 3 times per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy (TENS, ankle range of motion, and foot care). Exercises include a structured warm-up, ankle flexion ,extension, inversion , eversion , short walk ,calf and hamstring stretching 10 repetitions Followed by 20 minutes of multisensory training.Visual system activities (e.g., eye tracking ,follow moving object , circular eye movements and visual-motor coordination. Somatosensory exercises (walking on varying surfaces such as flat surface , mattresses and foam rubber). Proprioception/vestibular stimulation (e.g., unipedal stances, tandem stance , tandem walking( heel to toe walk), walking variations such as backward , forward, multidirectional walking, and cognitive dual-task obstacle navigation eg. functional mobility training .

Study groups in NCT07841730
Study groupRoleWhat they receive
Tibial Nerve MobilizationExperimentalNot described
Receives: Behavioral: Tibial Nerve Mobilization
Multisensory ExercisesActive comparatorNot described
Receives: Behavioral: Multisensory exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale (BBS)

    The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.

    Measured: Baseline and immediately after 4 weeks of intervention

Secondary outcomes (3)
  1. Short Form-12 Health Survey (SF-12)

    Quality of Life SF12 Questionnaire :

    The SF12 questionnaire used to assess the quality of life. It is a health related quality of life questionnaire including 12 questions.It has eight main which are some up into see physical and mental health. It has a scoring range from 0 to hundred for both physical as well as mental health.

    Measured: Baseline and immediately after 4 weeks of intervention

  2. SINBAD Scoring System:

    Foot condition severity will be assessed using the SINBAD classification system, which evaluates site, ischemia, bacterial infection, area, and depth.

    The SINBAD classification system will be used to assess the clinical status and severity of diabetic foot ulcer.

    Measured: Baseline and immediately after 4 weeks of intervention

  3. Toronto Clinical Neuropathy Score (TCNS)

    It is used to assess the severity of the diabetic foot neuropathy. It assess the sensory test, reflexes as well as symptoms. It scoring shows from 0 to 5 shows no diabetic peripheral neuropathy, 6 to 8 shows mild diabetic peripheral neuropathy, 9 to 11 shows moderate diabetic peripheral neuropathy and 12 to 19 shows severe diabetic peripheral neuropathy. It has a good reliability of 0.83 to 0.87. It also has a good validity of 0.713.

    Measured: Baseline and immediately after 4 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07841730
Sponsor's protocol ID
DFU Early grades26
Status last verified
Sep 2026
First submitted
19 Sep 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang L, Rong GC, Wu QN. Diabetic foot ulcer: Challenges and future. World J Diabetes. 2022 Dec 15;13(12):1014-1034. doi: 10.4239/wjd.v13.i12.1014.

    PubMed 36578870
  • Wang X, Yuan CX, Xu B, Yu Z. Diabetic foot ulcers: Classification, risk factors and management. World J Diabetes. 2022 Dec 15;13(12):1049-1065. doi: 10.4239/wjd.v13.i12.1049.

    PubMed 36578871
  • Waghe VR, Athawale V. Physiotherapeutic Interventions in Diabetic Foot Ulcer Management: A Case Report. Cureus. 2024 Feb 29;16(2):e55244. doi: 10.7759/cureus.55244. eCollection 2024 Feb.

    PubMed 38558580
  • Tran MM, Haley MN. Does exercise improve healing of diabetic foot ulcers? A systematic review. J Foot Ankle Res. 2021 Mar 20;14(1):19. doi: 10.1186/s13047-021-00456-w.

    PubMed 33743791
  • Ramachandran V, Mohanasundaram T, Karunakaran D, Gunasekaran M, Tiwari R. Physiological and Pathophysiological Aspects of Diabetic Foot Ulcer and its Treatment Strategies. Curr Diabetes Rev. 2023;19(8):e031122210617. doi: 10.2174/1573399819666221103141715.

    PubMed 36330634
  • McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023 Jan 1;46(1):209-221. doi: 10.2337/dci22-0043.

    PubMed 36548709
  • Liu X, Ren Q, Zhai Y, Kong Y, Chen D, Chang B. Risk Factors for Multidrug-Resistant Organisms Infection in Diabetic Foot Ulcer. Infect Drug Resist. 2022 Apr 7;15:1627-1635. doi: 10.2147/IDR.S359157. eCollection 2022.

    PubMed 35418765
  • Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.

    PubMed 40016658
  • Idiaquez JF, Alcantara M, Bril V. Optimal cut-off value of the modified Toronto Clinical Neuropathy Score in the diagnosis of polyneuropathy. Eur J Neurol. 2023 Aug;30(8):2481-2487. doi: 10.1111/ene.15870. Epub 2023 May 30.

    PubMed 37203998
  • Gupta G, Maiya GA, Bhat SN, Hande HM. Effect of Multifactorial Balance Rehabilitation Program on Risk of Falls and Functional Fitness in Older Adults with Diabetic Peripheral Neuropathy. Curr Aging Sci. 2023;16(3):240-247. doi: 10.2174/1874609816666230306150844.

    PubMed 37638589
  • Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec.

    PubMed 36404825
  • Chatzinikolaou A, Tzikas S, Lavdaniti M. Assessment of Quality of Life in Patients With Cardiovascular Disease Using the SF-36, MacNew, and EQ-5D-5L Questionnaires. Cureus. 2021 Sep 14;13(9):e17982. doi: 10.7759/cureus.17982. eCollection 2021 Sep.

    PubMed 34667665
  • Brocklehurst JD. The Validity and Reliability of the SINBAD Classification System for Diabetic Foot Ulcers. Adv Skin Wound Care. 2023 Nov 1;36(11):1-5. doi: 10.1097/ASW.0000000000000050.

    PubMed 37861669
  • Aagaard TV, Moeini S, Skou ST, Madsen UR, Brorson S. Benefits and Harms of Exercise Therapy for Patients With Diabetic Foot Ulcers: A Systematic Review. Int J Low Extrem Wounds. 2022 Sep;21(3):219-233. doi: 10.1177/1534734620954066. Epub 2020 Sep 14.

    PubMed 32924691
  • Aitken E, Hiew J, Hamilton EJ, Manning L, Ritter JC, Raby E, Gittings PM. Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety. J Foot Ankle Res. 2023 Mar 28;16(1):18. doi: 10.1186/s13047-023-00616-0.

    PubMed 36978157

Questions about this trial

What is this clinical trial studying?

A study testing Tibial Nerve Mobilization and Multisensory exercises in people with Diabetic Foot, run by University of Lahore.

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 11 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Sep 2026. 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?

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?

Berg Balance Scale (BBS) (time frame: Baseline and immediately after 4 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07841730, which also lists 20 linked publications.

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 Sep 2026.

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