Trial Outcomes & Findings for Instant Total Contact Cast to Heal Diabetic Foot Ulcers (NCT NCT01221207)
NCT ID: NCT01221207
Last Updated: 2020-08-24
Results Overview
We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
20 weeks
Results posted on
2020-08-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
43
|
66
|
54
|
|
Overall Study
NOT COMPLETED
|
32
|
9
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Instant Total Contact Cast (ITCC)
n=75 Participants
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.
|
Device - Total Contact Cast (TCC)
n=75 Participants
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.
|
Removable Cast Walker (RCW)
n=75 Participants
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.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.77 years
STANDARD_DEVIATION 11.99 • n=99 Participants
|
52.61 years
STANDARD_DEVIATION 10.73 • n=107 Participants
|
54.32 years
STANDARD_DEVIATION 12.61 • n=206 Participants
|
53.59 years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
179 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
43 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 20 weeksWe will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
Outcome measures
| Measure |
Instant Total Contact Cast (ITCC)
n=75 Participants
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.
|
Device - Total Contact Cast (TCC)
n=75 Participants
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.
|
Removable Cast Walker (RCW)
n=75 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Achieve Full Wound Healing.
|
35 Participants
|
63 Participants
|
37 Participants
|
Adverse Events
Instant Total Contact Cast (ITCC)
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Device - Total Contact Cast (TCC)
Serious events: 12 serious events
Other events: 38 other events
Deaths: 0 deaths
Removable Cast Walker (RCW)
Serious events: 13 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Instant Total Contact Cast (ITCC)
n=75 participants at risk
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.
|
Device - Total Contact Cast (TCC)
n=75 participants at risk
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.
|
Removable Cast Walker (RCW)
n=75 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Foot related readmission
|
9.3%
7/75 • Number of events 9 • 20 weeks
|
16.0%
12/75 • Number of events 14 • 20 weeks
|
17.3%
13/75 • Number of events 16 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
Non-foot related readmission
|
4.0%
3/75 • Number of events 3 • 20 weeks
|
0.00%
0/75 • 20 weeks
|
0.00%
0/75 • 20 weeks
|
Other adverse events
| Measure |
Instant Total Contact Cast (ITCC)
n=75 participants at risk
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.
|
Device - Total Contact Cast (TCC)
n=75 participants at risk
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.
|
Removable Cast Walker (RCW)
n=75 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Soft tissue infection
|
8.0%
6/75 • Number of events 10 • 20 weeks
|
10.7%
8/75 • Number of events 12 • 20 weeks
|
16.0%
12/75 • Number of events 13 • 20 weeks
|
|
Infections and infestations
Bone infection
|
8.0%
6/75 • Number of events 17 • 20 weeks
|
6.7%
5/75 • Number of events 10 • 20 weeks
|
9.3%
7/75 • Number of events 10 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
New foot ulcer
|
22.7%
17/75 • Number of events 30 • 20 weeks
|
30.7%
23/75 • Number of events 57 • 20 weeks
|
37.3%
28/75 • Number of events 57 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Mechanical fall
|
0.00%
0/75 • 20 weeks
|
2.7%
2/75 • Number of events 3 • 20 weeks
|
1.3%
1/75 • Number of events 3 • 20 weeks
|
|
Surgical and medical procedures
Minor amputation of foot
|
1.3%
1/75 • Number of events 2 • 20 weeks
|
1.3%
1/75 • Number of events 2 • 20 weeks
|
0.00%
0/75 • 20 weeks
|
Additional Information
Lawrence Lavery, DPM, MPH
UT Southwestern Medical Center at Dallas
Phone: 214-645-0544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place