Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04210089
Other study ID # ORSU-2019-28102
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date October 1, 2024

Study information

Verified date June 2024
Source University of Minnesota
Contact Joseph Schuster
Phone 612-273-9400
Email schus122@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.


Description:

This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods. The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be: - Unna boot from MPJs to just below the knee, - Sterile Kerlix from MPJs to just below the knee - Sterile 4 inch Kling wrap from the MPJs to just below the knee, - Four inch coban from MPJs to just below the knee, and - Ace wraps from MPJs to just below the knee Removable diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any adult with a diabetic foot ulcer Exclusion Criteria: - Allergy to Calamine or Zinc oxide - Inability to have leg wrapped - Inability to be seen weekly or as needed - Unable or unwilling to consent - Prisoners - Persons lacking capacity to consent

Study Design


Intervention

Device:
Total Contact Soft Cast
The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be: Unna boot from MPJs to just below the knee, Sterile Kerlix from MPJs to just below the knee Sterile 4 inch Kling wrap from the MPJs to just below the knee, Four inch coban from MPJs to just below the knee, and Ace wraps from MPJs to just below the knee
Cam Boot
Removable Diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use Diabetic cam boot then surgical shoe or regular shoe would be options.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Healing Rates Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days. 16 weeks
Secondary Patient Compliance with Use of the Total Contact Soft Cast The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated. 16 weeks
Secondary Patient Complications The percentage of patients who need to stop using the soft case due to complications will be calculated. 16 weeks
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A