Recruiting

Total Contact Soft Cast

Sponsor:

University of Minnesota

Code:

NCT04210089

Conditions

Diabetic Foot Ulcer

Diabetes Mellitus

Foot Ulcer

Foot Ulcer, Diabetic

Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Contact Soft Cast

Cam Boot

Study Details

Brief summary:

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

Conditions

Diabetic Foot Ulcer

Diabetes Mellitus

Foot Ulcer

Foot Ulcer, Diabetic

Ulcer

Study ID

NCT04210089

Start date

Oct 13, 2020

Status verified date

Oct, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Complete Healing Rates [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Joseph Schuster

612-273-9400schus122@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Joseph Schuster, DPM

612-273-9400schus122@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Oct 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.