Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer
Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study.
The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dr. Rubina Zulfqar
- Numéro de téléphone: +923414291664
- E-mail: drrubinazulfqar355@gmail.com
Lieux d'étude
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 38000
- Recrutement
- Dr Rubina Zulfqar
-
Contact:
- Dr. Rubina Zulfqar
- Numéro de téléphone: +923414291664
- E-mail: drrubinazulfqar355@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
- Patients with Wagner grade 1 diabetic foot ulcers was selected.
- Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
- Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
- Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
- Participants having diabetes for more than 10 years (Grewal et al., 2015).
- Pariticipants aged between 40 to 60 years.
- Both gender were included.
- Participants who was willing to give consent.
Exclusion Criteria:
- Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
- Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
- Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
- Participants who was not taking any medicine
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
|
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
|
|
Expérimental: Group B Ankle Range of Motion
Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
|
Parameters Description Ankle Range of Motion Active ROM
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vibration Perception Threshold
Délai: 6 week
|
Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not.
if person feel sensation grater than 10 second indicate decrease vibration perception.
|
6 week
|
|
Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).
Délai: 6 weeks
|
Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites.
One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.
|
6 weeks
|
|
Diabetic peripheral neuropathy
Délai: 6 weeks
|
Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.
|
6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Range of Motion
Délai: 6 weeks
|
Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.
|
6 weeks
|
|
Pain intensity
Délai: 6 weeks
|
Pain intensity will be measured by using Numerical Pain Rating Scale, the scale consisting of 0 to 10 number 0 means no pain 10 mean worse pain the decrease in NPRS scores reflecting decreased pain intensity and increased comfort.
|
6 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TUF/EIRB/174/26
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .