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Not yet recruitingNCT07841730Updated Nov 10, 2026

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

An interventional study of Tibial Nerve Mobilization and Multisensory exercises in Diabetic Foot, sponsored by University of Lahore. Not yet recruiting. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University of Lahore · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Start date movedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetic Foot

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Keywords

  • Tibial nerve mobilization
  • Multisensory Exercises
  • Diabetic foot ulcer
  • Diabetic Peripheral neuropathy
03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 38 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

University of Lahore is the lead sponsor of 232 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ≥ 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Presence of other systemic diseases apart from diabetes, such as 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Tibial Nerve Mobilization

    Behavioral: Tibial Nerve Mobilization

  • Active comparator
    Multisensory Exercises

    Behavioral: Multisensory exercises

Interventions

  • BehavioralTibial Nerve Mobilization

    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.

    Also known as: Nerve flossing, Neural Mobilization, Neural Gliding

  • BehavioralMultisensory exercises

    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 .

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline and immediately after 4 weeks of intervention

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline and immediately after 4 weeks of intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
  • Akkus G, Sert M. Diabetic foot ulcers: A devastating complication of diabetes mellitus continues non-stop in spite of new medical treatment modalities. World J Diabetes. 2022 Dec 15;13(12):1106-1121. doi: 10.4239/wjd.v13.i12.1106. PubMed 36578865 ↗
  • Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PubMed 37395769 ↗
  • Ashoori M, Hashemi SE, Pourahmadi M, Dadgoo M, Hosseini MS, Lotfi H, Ahmadi M. Adding tibial nerve neurodynamic techniques to a rehabilitative pain management strategy improved neuropathy severity and quality of life in patients with diabetic peripheral neuropathy: a randomized sham-controlled trial. BMC Complement Med Ther. 2025 Nov 24;25(1):429. doi: 10.1186/s12906-025-05168-3. PubMed 41286909 ↗
  • Azharuddin M, Parveen S, Noohu MM. Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review. J Chiropr Med. 2023 Dec;22(4):313-321. doi: 10.1016/j.jcm.2023.10.002. Epub 2023 Nov 18. PubMed 38205228 ↗
  • Alshimy, A. M., Ibrahim, S. M., Osama, L., & Metwally, H. M. (2023). Effect of neurodynamic mobilization techniques in patients with diabetic neuropathy. Human Movement, 24(3), 115-120.
09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 6 months is below that.

Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2026
First posted
Sep 25, 2026
StartEst.
Nov 2026was Sep 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 2026→Nov 2026
Nov 10, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Nov 10, 2026
    Start date Sep 2026→Nov 2026
    + 1 other change: verification date
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841730
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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