Health TrialsbyHealthPanel

Total Contact Soft Cast in Diabetic Foot Ulcers

ConditionsDiabetic Foot UlcerDiabetes MellitusFoot UlcerFoot Ulcer, DiabeticUlcerUlcer FootUlcer, LegAnkle Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Allergy to Calamine or Zinc oxide

Inability to have leg wrapped

Inability to be seen weekly or as needed

Unable or unwilling to consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Contact Soft Cast

    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

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Soft Cast with a Removable Cam BootExperimental treatment 2 interventions
Group B: Soft Cast without a Removable Cam BootExperimental treatment 1 intervention
Group C: ConventionalNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Complete Healing Rates

Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.

Time frame
16 weeks

Secondary outcomes

1

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.

Time frame
16 weeks
2

Patient Complications

The percentage of patients who need to stop using the soft case due to complications will be calculated.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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