Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 7:33 PM
Study NCT ID:
NCT07109895
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will be kept blinded of treatment group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a four-arm parallel-group interventional study designed to evaluate the effects of transcutaneous electrical nerve stimulation (TENS), custom insoles, and their combination in addition to standard care in patients with diabetic foot ulcers (DFUs). Participants will be randomly assigned to one of the following groups:\n\nGroup 1: Standard care alone Group 2: TENS + standard care Group 3: Custom insole + standard care Group 4: TENS + custom insole + standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.', 'description': 'Pain intensity will be measured using a visual analogue scale. It is an 11-point scale where "0" indicates no pain and "10" indicates the worst possible pain.'}, {'measure': 'Dynamic Balance:', 'timeFrame': 'Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.', 'description': 'The time up and go (TUG) scale will be used for measuring dynamic balance. A time score of ≤10 seconds is considered normal, and a time of ≥14 seconds has been shown to indicate a high risk of falls.'}, {'measure': 'Wound Healing', 'timeFrame': 'Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.', 'description': 'Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.'}], 'secondaryOutcomes': [{'measure': 'Risk of fall', 'timeFrame': 'Risk of fall will be measured at baseline, and change in status will be measured at the 4th week, 8th week, and 12th week of the treatment session.', 'description': 'The Tinetti Scale will be used to measure the risk of fall. The final score of the scale is 28 points, and the interpretation is as follows: 25-28 = low risk of falls; 19-24 = moderate risk of falls; and \\<19 = high risk of falls.'}, {'measure': 'Toe Muscle Strength', 'timeFrame': 'Toe Muscle Strength will be measured at baseline, and change in strength will be measured at the 4th week, 8th week, and 12th week of the treatment session.', 'description': 'The paper grip test (PGT) will be used to measure toe muscle strength.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Disability', 'Diabetic Foot Ulcer', 'Transcutaneous Electrical Nerve Stimulation', 'Customized Insole', 'Pain', 'Dynamic Balance', 'Risk of Fall', 'Wound Size', 'Wound Depth', 'Diabetes'], 'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.', 'detailedDescription': 'Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.\n\nOffloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-60 years old with type 1 and 2 diabetes\n2. Both Males and Females\n3. Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification\n\nExclusion Criteria:\n\n1. History of amputation (proximal to the trans-metatarsal joint)\n2. Active or inactive Charcot foot\n3. Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)\n4. Leg length discrepancy\n5. The presence of any allergic condition of the skin,\n6. Chronic consumption of opioids,\n7. Use of a cardiac pacemaker,\n8. Major bone operation,\n9. Neurological illness, such as a vestibular disorder with a history of dizziness 10. Mental disorders, which might interfere with the assessment process\n\n11\\. Dementia or impaired cognitive function'}, 'identificationModule': {'nctId': 'NCT07109895', 'briefTitle': 'Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'Custom Insole with TENS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Care Only', 'description': 'Participants will receive standard care for diabetic foot ulcers.', 'interventionNames': ['Other: Standard Care Only']}, {'type': 'EXPERIMENTAL', 'label': 'Custom Insole + Standard Care', 'description': 'Participants will receive a custom insole along with standard care.', 'interventionNames': ['Other: Custom Insole + Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'TENS + Custom Insole + Standard Care', 'description': 'Participants will receive TENS therapy, a custom insole, and standard care.', 'interventionNames': ['Other: TENS + Custom Insole + Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'TENS + Standard Care', 'description': 'Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.', 'interventionNames': ['Other: TENS plus Standard Care']}], 'interventions': [{'name': 'Standard Care Only', 'type': 'OTHER', 'description': 'Standard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.', 'armGroupLabels': ['Standard Care Only']}, {'name': 'TENS plus Standard Care', 'type': 'OTHER', 'description': 'This experimental group will receive the same intervention plus Transcutaneous Electrical Nerve Stimulation (TENS) in burst mode (1-4 Hz at 100 Hz) applied around the wound site for 30 minutes, along with standard care.', 'armGroupLabels': ['TENS + Standard Care']}, {'name': 'Custom Insole + Standard Care', 'type': 'OTHER', 'description': 'The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.', 'armGroupLabels': ['Custom Insole + Standard Care']}, {'name': 'TENS + Custom Insole + Standard Care', 'type': 'OTHER', 'description': 'Participants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs).', 'armGroupLabels': ['TENS + Custom Insole + Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Ayesha Jamil, M.Phil Physiotherapy', 'role': 'CONTACT', 'email': 'ayeshabutt031@gmail.com', 'phone': '+92 324 4481031'}, {'name': 'Maryam Shabbir, PhD Rehabilitation', 'role': 'CONTACT', 'email': 'maryam.shabbir@uipt.uol.edu', 'phoneExt': '+923004391550'}, {'name': 'Ayesha Jamil, M. Phil Physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Ayesha Jamil, M.Phil Physiotherapy', 'role': 'CONTACT', 'email': 'ayeshabutt031@gmail.com', 'phone': '+92 324 4481031'}, {'name': 'Maryam Shabbir, PhD Rehabilitation', 'role': 'CONTACT', 'email': 'maryam.shabbir@uipt.uol.edu.pk', 'phone': '+92 300 4391550'}], 'overallOfficials': [{'name': 'Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Will be share after publication', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ayesha Jamil', 'investigatorAffiliation': 'University of Lahore'}}}}