Diabetic Foot UlcerNCT04210089
Total Contact Soft Cast in Diabetic Foot Ulcers
A study testing Total Contact Soft Cast and Cam Boot in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
Trial summary
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer
- What is being tested?
- Total Contact Soft Cast and Cam Boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult with a diabetic foot ulcer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Joseph Schuster, DPM, 612-273-9400, schus122@umn.edu
About this study
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Read the 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
- Being tested
- Total Contact Soft Cast, Cam Boot
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer, Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Contact Soft CastDevice
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 BootDevice
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 group | Role | What they receive |
|---|---|---|
| Soft Cast with a Removable Cam Boot | Experimental | 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. Receives: Device: Total Contact Soft Cast; Device: Cam Boot |
| Soft Cast without a Removable Cam Boot | Experimental | 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. Receives: Device: Total Contact Soft Cast |
| Conventional | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Healing Rates
Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.
Measured: 16 weeks
Secondary outcomes (2)
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.
Measured: 16 weeks
Patient Complications
The percentage of patients who need to stop using the soft case due to complications will be calculated.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start13 Oct 2020
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Schuster, DPM, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210089
- Sponsor's protocol ID
- ORSU-2019-28102
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Contact Soft Cast in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04210089
- Acronym / sponsor ID
- ORSU-2019-28102
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer, Foot Ulcer, Diabetic, Ulcer, Ulcer Foot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soft Cast with a Removable Cam Boot | Experimental | Device: Total Contact Soft Cast, Device: Cam BootPatients 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. |
| Soft Cast without a Removable Cam Boot | Experimental | Device: Total Contact Soft CastPatients 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. |
| Conventional | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult with a diabetic foot ulcer
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Contact Soft CastThe 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 | Soft Cast with a Removable Cam Boot, Soft Cast without a Removable Cam Boot |
| Cam BootRemovable 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. | Device | Soft Cast with a Removable Cam Boot |
Primary outcome
Complete Healing Rates
Time frame: 16 weeks
Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.
2 secondary outcomes
Patient Compliance with Use of the Total Contact Soft Cast
Time frame: 16 weeks
Patient Complications
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Schuster, DPM principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Contact Soft Cast and Cam Boot in people with Diabetic Foot Ulcer and Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Schuster (612-273-9400, schus122@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Healing Rates (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.