Clinical trials: Plantar Ulcers
Diabetic Neuropathy
Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS).
- Trial name
- LEEF-shoe (NCT07488104)
- Testing
- LEEF-shoe, standard orthopaedic shoe
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- University Medical Center Groningen
Foot Ulcer
Functional Ankle Taping Correction on Plantar Foot Ulcer Healing in Diabetic Patients
This study will investigate the effects of Functional ankle taping correction on plantar foot ulcer healing in diabetic patients.
- Trial name
- NCT06065488
- Testing
- ankle kinesio tap
- Where
- Egypt
- Volunteers
- 74 people
- Sponsor
- MTI University
Diabetic Foot, Diabetes
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030.
- Trial name
- NCT03254095
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
Diabete Mellitus, Peripheral Neuropathy
The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements.
- Trial name
- Siliconepads (NCT07172763)
- Testing
- Siliconepad, Felted foam
- Volunteers
- 80 people
- Sponsor
- University Hospital, Ghent
Pressure Ulcers
Creation of a Pressure Reducing Areas in Socks
Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.
- Trial name
- NCT00351312
- Testing
- special socks
- Where
- Israel
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center
Diabetic Foot Ulcer, Venous Ulcer
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and…
- Trial name
- NCT00338923
- Testing
- HO/03/03
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- HealOr
Diabetes Complications
Abnormal Plantar Pressure in Patients With Diabetes
The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known.
- Trial name
- NCT03426566
- Testing
- retrospective observational study with no intervention
- Where
- Poland
- Volunteers
- 974 people
- Sponsor
- Wroclaw Medical University
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD
Diabetes Mellitus, Hyperkeratosis
Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
This randomized clinical trial aims to compare the diagnostic performance, reproducibility, and agreement of several non-invasive instrumental methods for assessing plantar hyperkeratosis hardness in healthy subjects and patients…
- Trial name
- NCT07412561
- Testing
- Instrumental Assessment of Plantar Hyperkeratosis
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Seville
Diabetic Foot Ulcer (DFU), Orthoses
The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance…
- Conditions
- Diabetic Foot Ulcer (DFU), Orthoses, Postural Balance, Plantar Pressure Distrubution
- Trial name
- NCT06846476
- Testing
- Insole, Demographic Information and Anamnesis Form, Pedobarographic analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 25 people
- Sponsor
- Medipol University
Diabetic Foot Ulcer, Wound Healing
Tele-Exercise Platform for Plantar Wound Healing
The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to…
- Conditions
- Diabetic Foot Ulcer, Wound Healing, Wound Care
- Trial name
- Tele-FootX (NCT06439667)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Diabetic Foot Ulcer
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional…
- Trial name
- NCT01181440
- Testing
- Dermagraft(R), Conventional care
- Where
- United States
- Volunteers
- 281 people
- Sponsor
- Organogenesis
Diabetes, Diabetic Foot
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure.
- Conditions
- Diabetes, Diabetic Foot, Plantar Ulcer, Neuropathy
- Trial name
- Diab10 (NCT04054076)
- Testing
- Prefabricated insoles, Soft custom-made insoles, Hard custom-made insoles
- Where
- Sweden
- Volunteers
- 224 people
- Sponsor
- Sahlgrenska University Hospital
Diabetic Foot, Diabetic Neuropathies
3D Printed vs Ready-to-Wear Insoles for Diabetic Neuropathy
Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility.
- Trial name
- 3DP-DPN (NCT07641764)
- Testing
- 3D Printed Customized Insole, Ready-to-Wear Insole
- Where
- Pakistan
- Volunteers
- 22 people
- Sponsor
- University of Faisalabad
Diabetes Mellitus, Foot Ulcer
Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers
People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast.
- Conditions
- Diabetes Mellitus, Foot Ulcer, Peripheral Neuropathy
- Trial name
- NCT00006426
- Testing
- Achilles tendon-lengthening surgery
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Diabetic Foot, Plantar Fasciitis
Joints Mobilization Versus Myofascial Release on Diabetic Patients With Painful Heel
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.
- Trial name
- NCT03851848
- Testing
- Joint mobilization (JM), Myofascial release (MFR)
- Where
- Saudi Arabia
- Volunteers
- 46 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
Foot Ulcer, Diabetic
Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design
The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.
- Trial name
- NCT01699100
- Testing
- device
- Volunteers
- 26 people
- Sponsor
- Taichung Veterans General Hospital
Diabetic Foot Ulcer
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects.
- Trial name
- STRIDE 5 (NCT01840085)
- Testing
- 0.03% DSC127 topical gel
- Where
- 21 sites in United States
- Volunteers
- 261 people
- Sponsor
- Integra LifeSciences Corporation
Plantar Ulcer, Diabetes
The CareFUL Prevention Trial
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes…
- Conditions
- Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation
- Trial name
- CareFULPrevent (NCT00803608)
- Testing
- TrueContour® Insole, Current standard of care insole
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- DIApedia, LLC
Diabete Type 2, Diabetic Foot
Prevalence of the Appearance of Diabetic Ulcers in Patients With 3D Insole and LSCI.
Diabetes is a serious and chronic disease that affects more than 347 million people in the world. It is the leading cause of death by age and its prevalence is increasing annually throughout the world.
- Conditions
- Diabete Type 2, Diabetic Foot, Neuropathy, Diabetic, Vascular Disease, Peripheral
- Trial name
- MYFOOT-C (NCT05843929)
- Testing
- LSCI
- Volunteers
- 86 people
- Sponsor
- Esther Soler