Clinical Trials Logo

Clinical Trial Summary

Diabetes mellitus (DM) increases stiffness and thickness of foot structures. This may alter the foot's biomechanics and increase plantar pressure distribution, mainly on the forefoot region. Presence of plantar heel pain (PHP) also may alter the foot's rollover mechanism and increase plantar loading in the forefoot as a protective mechanism of pain. The risk of diabetic ulcer formation increases with these restricted ankle range of motion (ROM) and increased foot plantar pressure that may present in DM patient with PHP.

The association that has been established previously between limited ankle ROM and PHP leads to a reasonable utilization of joint and soft tissue mobilization in treating diabetic patients with PHP. The aim of this study is to investigate the immediate and short-term effect of a single session of ankle and foot joint mobilization (JM) versus Myofascial release (MFR) on pain intensity, ankle ROM, foot plantar pressure, dynamic and static balance, and functional level of diabetic patients with PHP.

The findings of this study will help to understand the effect of these two interventions on diabetic patients with PHP in term of the previously mentioned parameters. This may guide the physiotherapists to choose the best available technique to treat DM patients with PHP, and that may help to reduce the risk of DM foot complications.


Clinical Trial Description

It is a clinical experimental study of 46 controlled diabetic patients (type II) above 30 years with unilateral PHP who will present to physiotherapy screening clinic through the medical referral. The participants will be evaluated then distributed randomly to receive a single session of either JM or MFR followed by an immediate reassessment and a follow-up reassessment after 2 weeks. The assessment will include ankle ROM, pain intensity (visual analog scale), static balance (one leg stance test), dynamic balance (time up and go test), plantar pressure distribution, and functional level (lower extremity functional scale LEFS). Analysis of parametric data will be done using ANOVA for the repeated measure. LEFS score will be calculated using Mann-Whitney U test for nonparametric data. Alpha < 0.05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03851848
Study type Interventional
Source Imam Abdulrahman Bin Faisal University
Contact Deanship of Graduate Studies
Phone +9661333 32562
Email gs@iau.edu.sa
Status Recruiting
Phase N/A
Start date March 3, 2019
Completion date March 2020

See also
  Status Clinical Trial Phase
Recruiting NCT06154915 - Immune Cells in Diabetic Chronic Foot Ulcers
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Completed NCT02373592 - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer N/A
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01212120 - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT04085705 - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT04537676 - Patient Empowerment Study
Completed NCT04480801 - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Recruiting NCT05974592 - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program N/A
Not yet recruiting NCT04630795 - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting NCT05431660 - Diabetic Foot School and Biomechanics N/A
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Completed NCT05123157 - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT03254095 - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Terminated NCT01657318 - Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers