NCT04210089

Total Contact Soft Cast in Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Foot Ulcer
• Diabetes Mellitus
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer
• Ulcer Foot
• Ulcer, Leg
• Ankle Ulcer

Interventions

Type	Name	Description
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
DEVICE	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.

Timeline

• Start date: 2020-10-13
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2019-12-24
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study