Clinical trials: Offloading
Charcot Neuroarthropathy
Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot.
- Trial name
- NCT06573554
- Testing
- Total Contact Cast, Posterior Slab
- Where
- India
- Volunteers
- 80 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Diabetic Foot, Neuropathy
Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish…
- Conditions
- Diabetic Foot, Neuropathy, Quality of Life
- Trial name
- NCT01663519
- Testing
- Custom made insoles 35 shore, Prefabricated insoles, 55 shore Custom made insole
- Where
- Sweden
- Volunteers
- 114 people
- Sponsor
- Sahlgrenska University Hospital
Diabetes Mellitus, Foot Ulcer
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation.
- Trial name
- NCT05415878
- Testing
- RCW design form
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rosalind Franklin University of Medicine and Science
Metatarsalgia, Hyperkeratotic Callus
Pressure Offloading Injectible System With the Use of Juvederm Voluma in the Foot
The current use of Juvederm Voluma XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.
- Conditions
- Metatarsalgia, Hyperkeratotic Callus, Corns, Fat Pad Syndrome
- Trial name
- POIS (NCT04103866)
- Testing
- Juvederm Voluma
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Schoenhaus, Jodi, DPM
Cardiovascular Diseases, Chronic Heart Failure
FLOWS-HF : Feasibility of Lymphatic Offloading With Stenting in Heart Failure
The main objective is to evaluate the safety of lymphatic decompression in heart failure. The research hypothesis is that lymphatic decompression is safe and feasible in heart failure patients with recurrent congestion despite on…
- Trial name
- FLOW-HF (NCT06554912)
- Testing
- Lymphatic Decompression
- Sponsor
- University Hospital, Grenoble
Diabetic Foot Ulcer (DFU)
Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients.
- Trial name
- NCT06670417
- Testing
- Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light, Buerger Allen exercise, Regular wound care
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Cairo University
Diabetic Foot Ulcer, Offloading
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected.
- Trial name
- NCT02783066
- Testing
- Offloading boot: PulseFlow
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Baylor College of Medicine
Diabetic Complications, Foot Care
Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers.
- Trial name
- NCT07620379
- Testing
- felt padding
- Where
- Spain
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- University of Valencia
Diabetic Foot Ulcer
Surgical Offloading Procedures for Diabetic Foot Ulcers
100 consenting subjects with Texas grade 1a diabetic foot ulcers will be randomized to surgical offloading or non-operative offloading.
- Trial name
- NCT03414216
- Testing
- Group 1 early offloading surgery, Group 2 - off-loading in fiberglass cast
- Volunteers
- 100 people
- Sponsor
- Assaf Harofeh MC
Heel Pressure Ulceration Prevention Strategies
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
Prevention of heel pressure ulceration is a major clinical concern. Clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading…
- Trial name
- NCT02811965
- Testing
- Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Plantar Fasciitis, Chronic, Heel Pain Syndrome
Validation of a Novel Foot Offloading Device
Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where there…
- Conditions
- Plantar Fasciitis, Chronic, Heel Pain Syndrome, Fat Pad Syndrome
- Trial name
- PopSole2 (NCT04378270)
- Testing
- PopSole™ Offloading Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Jeffrey A. Gusenoff, MD
Osteoarthritis, Knee
Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.
- Trial name
- UNIBRACE (NCT05905809)
- Testing
- UniRelieverTM offloading brace (THUASNE), Unloader One® X brace (Össur)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Thuasne
Diabetic Foot
Physical Activity Assessment of Patients With Diabetic Foot Wounds
The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition.
- Trial name
- EFADDIAP (NCT04582357)
- Testing
- Physical activity program
- Sponsor
- University Hospital, Lille
Diabetic Foot Ulcer
Smart Boot Use to Measure Offloading Adherence
The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation.
- Trial name
- NCT04460573
- Testing
- Offloading Boot
- Where
- 4 sites in United States
- Volunteers
- 210 people
- Sponsor
- University of Southern California
Diabetic Foot Ulcer, Diabetic Foot
Adapting Lifestyle Offloading for DFUs
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care.
- Trial name
- NCT06278935
- Testing
- Lifestyle-based intervention by an occupational therapist
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Southern California
Plantar Fascitis, Fat Pad Syndrome
Offloading Device for Post Surgical Foot Procedures
Study goals are to determine if a novel post-surgical foot offloading device can reduce post-operative pain and expedite the return to daily activity following fat grafting.
- Trial name
- NCT03873207
- Testing
- PopSole™ offloading device, padded insole
- Where
- United States
- Sponsor
- Jeffrey A. Gusenoff, MD
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 (DFU), Offloading
Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers
The goal of this clinical trial is to compare wound healing and foot related outcomes in people with plantar diabetic foot ulcer using Total contact cast (TCC) or Posterior slab cast (PSC).
- Trial name
- NCT07111741
- Testing
- Total contact cast, Posterior slab cast
- Where
- India
- Volunteers
- 99 people
- Sponsor
- ILS Hospital, Salt Lake
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Trial name
- FOCUS 3D (NCT07632001)
- Testing
- Miro3D Wound Matrix, Standard of Care
- Where
- 14 sites in United States
- Volunteers
- 180 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot, Diabetic Peripheral Neuropathy
Activity Reduction vs Advice for Plantar Hotspots in Diabetes
This randomized proof-of-concept trial will evaluate whether an individualized, objectively monitored temporary reduction in walking activity can accelerate resolution of plantar thermal hotspots in adults with diabetes who are…
- Trial name
- MONITOR (NCT07840300)
- Testing
- Individualized Objectively Monitored Activity Reduction, Standard Activity-Reduction Advice
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- Shifa International Hospital