Total Contact Soft Cast in Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2026-10-01

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Soft Cast with a Removable Cam Boot

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast with removable cam boot.

Group Type EXPERIMENTAL

Total Contact Soft Cast

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Soft Cast without a Removable Cam Boot

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast.

Group Type EXPERIMENTAL

Total Contact Soft Cast

Intervention Type DEVICE

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

Conventional

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will use conventional offloading including total contact casting, removable cast boots (cam boots), CROW boots, bracing, AFO's, offloading shoes, insoles, padding, shoe modifications, crutches, wheelchairs, rollabout, and surgical correction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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