Smart Boot Use to Measure Offloading Adherence

Status Recruiting

Clinical Trial Summary

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. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04460573
Study type	Interventional
Source	University of Southern California
Contact	Jason Garcia, BA
Phone	323-680-0196
Email	Jason.garcia@med.usc.edu
Status	Recruiting
Phase	Phase 2
Start date	October 19, 2021
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04497805` - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers	Phase 2
Withdrawn	`NCT03675269` - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:	N/A
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Not yet recruiting	`NCT06439667` - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting	`NCT05608187` - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers	Phase 2
Not yet recruiting	`NCT06437028` - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.	N/A
Not yet recruiting	`NCT06278935` - Lifestyle Tailored Offloading for Diabetic Foot Ulcers	N/A
Withdrawn	`NCT05024656` - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers	N/A
Terminated	`NCT02202668` - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers	N/A
Completed	`NCT01951768` - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection	Phase 4
Terminated	`NCT01966380` - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia	Phase 2
Completed	`NCT01657474` - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers	N/A
Active, not recruiting	`NCT00389636` - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	N/A
Completed	`NCT01181440` - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers	Phase 3
Enrolling by invitation	`NCT05888259` - Plantar Pressure Distribution in Diabetic Foot Ulcer	N/A
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting	`NCT05877378` - Efficacy of PICO Single-use System in Chronic Ulcers	N/A
Recruiting	`NCT06037369` - The Short Message-based Customized Standardized	N/A
Completed	`NCT03312595` - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)	N/A
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A