Diabetic FootNCT06479577
US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot
A study testing ultrasound and high intensity laser therapy in people with Diabetic Foot and Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Diabetic Foot, Diabetic Neuropathies
- What is being tested?
- ultrasound and high intensity laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 1 Jul 2024
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes.
- Diabetic Patients of age 50 to 75 years.
- Diabetic patient of Both genders
- Diagnosed Diabetes Mellitus with at least 7 years of duration
- Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for ≥6 months
- DNS (Diabetic neuropathy symptoms questionnaire) score greater than 4 (90 percent probability of neuropath
Who cannot join
- Pregnant females
- Lower limb Amputated patients
- History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus.
- Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapses and lumbar spine associated radiculopathy.
- History of any low back surgeries and lower limb surgeries
- Patient with malignancy. Patient with epilepsy
Show all 10Show fewer
- Patient with hemophilia
- Patient with pacemaker, metal implants prosthesis and internal fixation screws.
- Patient with severe cervical and lumbar neuropathy, rheumatoid arthritis, hereditary neuropathy
- Patient with a history of neurosurgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bahawalpur medical and dental hospital
Bahawalpur, Punjab Province, 63100
Hira Jabeen, 03234116506, hira.jabeen@riphah.edu.pk
Zara Tariq, Ms (nmpt)
About this study
Official title: Comparative Effects of Therapeutic Ultrasound and High Intensity Laser Therapy on Neuropathic Pain ,Strength and Quality of Life in Diabetic Foot
To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot
Read the detailed description
therapeutic ultrasound and laser therapy with routine physical therapy are used to improve neuropathic pain and foot related quality of life. the scarcity of evidence regarding the application of high intensity laser therapy necessitates a comprehensive investigation. The effects of HILT and comparative effects with ultrasound remains largely unexplored in diabetic peripheral neuropathy
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Being tested
- ultrasound, high intensity laser therapy
- Keywords
- diabetic neuropathies
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
ultrasound 1 MHZ continuous for 20 minute with routine physical therapy 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set
high intensity laser therapyOther
905 nm super pulsed laser 40 minute session 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Experimental | therapeutic ultrasound 1MHZ continuous mode for 20 minutes Receives: Other: ultrasound |
| high intensity laser therapy | Active comparator | approximately 905 nm super pulsed laser Receives: Other: high intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
michigan neuropathy screening instrument
MNSI is designed to screen for the presence of diabetic neuropathy the first part consist of 15 self administered questions on foot sensations ,pain ,numbness etc second part is brief physical examination of feet
Measured: 8th week
foot and ankle disability index
FADI is designed to assess functional limitations related to foot and ankle conditions it has 26 items each item scored from 0 -4 FADI has totel 104 points
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Feb 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479577
- Sponsor's protocol ID
- REC/RCR/23/02101 Zara Tariq
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020.
PubMed 33194943Lin L, Li J, Lin J, Tang S, Li Y. Effectiveness and safety of low-level laser therapy in diabetic peripheral neuropathy: a protocol for a systematic review and meta-analysis. Syst Rev. 2021 Apr 2;10(1):96. doi: 10.1186/s13643-021-01656-y.
PubMed 33810813Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2020 Dec;50:102220. doi: 10.1016/j.msksp.2020.102220. Epub 2020 Jul 24.
PubMed 32827852Eun IS, Oh YS, Kim J, Jang W. Reliability and Validity of the Korean Version of Foot and Ankle Disability Index. J Foot Ankle Surg. 2024 Jan-Feb;63(1):33-35. doi: 10.1053/j.jfas.2023.08.007. Epub 2023 Aug 19.
PubMed 37604317Seyedizadeh SH, Cheragh-Birjandi S, Hamedi Nia MR. The Effects of Combined Exercise Training (Resistance-Aerobic) on Serum Kinesin and Physical Function in Type 2 Diabetes Patients with Diabetic Peripheral Neuropathy (Randomized Controlled Trials). J Diabetes Res. 2020 Mar 6;2020:6978128. doi: 10.1155/2020/6978128. eCollection 2020.
PubMed 32215272
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Therapeutic Ultrasound and High Intensity Laser Therapy on Neuropathic Pain ,Strength and Quality of Life in Diabetic Foot
- ClinicalTrials.gov ID
- NCT06479577
- Acronym / sponsor ID
- REC/RCR/23/02101 Zara Tariq
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Keywords
- diabetic neuropathies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 28 Jun 2024 (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.
To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot
Detailed description
therapeutic ultrasound and laser therapy with routine physical therapy are used to improve neuropathic pain and foot related quality of life. the scarcity of evidence regarding the application of high intensity laser therapy necessitates a comprehensive investigation. The effects of HILT and comparative effects with ultrasound remains largely unexplored in diabetic peripheral neuropathy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Experimental | Other: ultrasoundtherapeutic ultrasound 1MHZ continuous mode for 20 minutes |
| high intensity laser therapy | Active comparator | Other: high intensity laser therapyapproximately 905 nm super pulsed laser |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with type 2 diabetes.
- Diabetic Patients of age 50 to 75 years.
- Diabetic patient of Both genders
- Diagnosed Diabetes Mellitus with at least 7 years of duration
- Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for ≥6 months
Key exclusion criteria (10 listed)
- Pregnant females
- Lower limb Amputated patients
- History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus.
- Patient with malignancy. Patient with epilepsy
- Patient with hemophilia
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 |
|---|---|---|
| ultrasoundultrasound 1 MHZ continuous for 20 minute with routine physical therapy 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set | Other | ultrasound |
| high intensity laser therapy905 nm super pulsed laser 40 minute session 3 days /week 150 minutes/ week resistance training 5-10 exercises involving major muscles of leg and foot 3-4 sets per exercise and 10- 15 repetition per set | Other | high intensity laser therapy |
Primary outcome
michigan neuropathy screening instrument
Time frame: 8th week
MNSI is designed to screen for the presence of diabetic neuropathy the first part consist of 15 self administered questions on foot sensations ,pain ,numbness etc second part is brief physical examination of feet
foot and ankle disability index
Time frame: 8th week
FADI is designed to assess functional limitations related to foot and ankle conditions it has 26 items each item scored from 0 -4 FADI has totel 104 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 33194943Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020.
- Background: PubMed 33810813Lin L, Li J, Lin J, Tang S, Li Y. Effectiveness and safety of low-level laser therapy in diabetic peripheral neuropathy: a protocol for a systematic review and meta-analysis. Syst Rev. 2021 Apr 2;10(1):96. doi: 10.1186/s13643-021-01656-y.
- Background: PubMed 32827852Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2020 Dec;50:102220. doi: 10.1016/j.msksp.2020.102220. Epub 2020 Jul 24.
- Background: PubMed 37604317Eun IS, Oh YS, Kim J, Jang W. Reliability and Validity of the Korean Version of Foot and Ankle Disability Index. J Foot Ankle Surg. 2024 Jan-Feb;63(1):33-35. doi: 10.1053/j.jfas.2023.08.007. Epub 2023 Aug 19.
- Background: PubMed 32215272Seyedizadeh SH, Cheragh-Birjandi S, Hamedi Nia MR. The Effects of Combined Exercise Training (Resistance-Aerobic) on Serum Kinesin and Physical Function in Type 2 Diabetes Patients with Diabetic Peripheral Neuropathy (Randomized Controlled Trials). J Diabetes Res. 2020 Mar 6;2020:6978128. doi: 10.1155/2020/6978128. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Aruba Saeed, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and high intensity laser therapy in people with Diabetic Foot and Diabetic Neuropathies, run by Riphah International 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 10 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
michigan neuropathy screening instrument (time frame: 8th week). The study lists 2 primary outcomes in all. 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 NCT06479577, which also lists 5 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 28 Jun 2024.