Diabetic Foot Ulcers
Conditions
Keywords
diabetic foot ulcers, casting, wound care
Brief summary
Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics. Aim 2. To compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with TCC, ITCC and RCW to heal diabetic foot ulcers. Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment groups. Using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups. Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.
Detailed description
This is an investigator blinded randomized, controlled clinical trial with three parallel treatment groups of 75 adult outpatients with diabetes mellitus and a foot ulcer. The study will be conducted at five university affiliated medical centers in Arizona and Texas. The study participants and nurse coordinator will not be blinded to the treatment after randomization. Investigators will be blinded to treatment group assignment.
Interventions
DEVICETotal Contact Cast
A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.
DEVICEInstant Total Contact Cast (ITCC)
The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.
DEVICERemovable Cast Walker (RCW)
The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women 18 years old or older * One or more foot ulcers without clinical evidence of osteomyelitis * Diagnosis of Diabetes Mellitus * University of Texas Grade 1A-B, 2A-B or 3A-B * ABI \>0.5 * Spanish-speaking subjects will be eligible to participate
Exclusion criteria
* Active Charcot Arthropathy * ABI \<0.5 * Gangrene, active infection * Unable to keep research appointments * Wide spread malignancy or systemically immunocompromising disease * Alcohol or substance abuse within 6 months * Unreliable, unwilling or unable to comprehend informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve Full Wound Healing. | 20 weeks | We will evaluate wounds at each clinical visit. An ulcer will be considered healed when it is fully epithelialized with no drainage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Instant Total Contact Cast (ITCC) The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.
Instant Total Contact Cast (ITCC): The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician. | 75 |
| Device - Total Contact Cast (TCC) A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.
Total Contact Cast: A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing. | 75 |
| Removable Cast Walker (RCW) The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.
Removable Cast Walker (RCW): The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot. | 75 |
| Total | 225 |
Baseline characteristics
| Characteristic | Instant Total Contact Cast (ITCC) | Device - Total Contact Cast (TCC) | Removable Cast Walker (RCW) | Total |
|---|---|---|---|---|
| Age, Continuous | 53.77 years STANDARD_DEVIATION 11.99 | 52.61 years STANDARD_DEVIATION 10.73 | 54.32 years STANDARD_DEVIATION 12.61 | 53.59 years STANDARD_DEVIATION 11.79 |
| Race/Ethnicity, Customized African American | 6 Participants | 13 Participants | 12 Participants | 31 Participants |
| Race/Ethnicity, Customized Caucasian | 43 Participants | 33 Participants | 34 Participants | 110 Participants |
| Race/Ethnicity, Customized Hispanic | 25 Participants | 27 Participants | 26 Participants | 78 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 19 Participants | 12 Participants | 15 Participants | 46 Participants |
| Sex: Female, Male Male | 56 Participants | 63 Participants | 60 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 30 / 75 | 38 / 75 | 48 / 75 |
| serious Total, serious adverse events | 7 / 75 | 12 / 75 | 13 / 75 |
Outcome results
Primary
Number of Participants Who Achieve Full Wound Healing.
We will evaluate wounds at each clinical visit. An ulcer will be considered healed when it is fully epithelialized with no drainage.
Time frame: 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Instant Total Contact Cast (ITCC) | Number of Participants Who Achieve Full Wound Healing. | 35 Participants |
| Device - Total Contact Cast (TCC) | Number of Participants Who Achieve Full Wound Healing. | 63 Participants |
| Removable Cast Walker (RCW) | Number of Participants Who Achieve Full Wound Healing. | 37 Participants |