Total Contact Soft Cast in Diabetic Foot Ulcers

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04210089

Enrollment

100

Registered

2019-12-24

Start date

2020-10-13

Completion date

2026-10-01

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICETotal 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

DEVICECam 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Healing Rates	16 weeks	Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.

Secondary

Measure	Time frame	Description
Patient Compliance with Use of the Total Contact Soft Cast	16 weeks	The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated.
Patient Complications	16 weeks	The percentage of patients who need to stop using the soft case due to complications will be calculated.

Countries

United States

Contacts

Primary ContactJoseph Schuster

schus122@umn.edu612-273-9400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026