Trial Outcomes & Findings for Therapeutic Stockings to Prevent Foot Ulcers (NCT NCT01221194)
NCT ID: NCT01221194
Last Updated: 2020-08-26
Results Overview
An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
381 participants
Primary outcome timeframe
30 months
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
PFC Stockings
The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
|
Standard Therapy
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
|---|---|---|
|
Overall Study
STARTED
|
195
|
186
|
|
Overall Study
COMPLETED
|
195
|
186
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Stockings to Prevent Foot Ulcers
Baseline characteristics by cohort
| Measure |
PFC Stockings
n=195 Participants
The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
|
Standard Therapy
n=186 Participants
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.06 years
STANDARD_DEVIATION 11.14 • n=99 Participants
|
56.08 years
STANDARD_DEVIATION 6.76 • n=107 Participants
|
53.72 years
STANDARD_DEVIATION 9.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
269 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=99 Participants
|
109 participants
n=107 Participants
|
234 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
70 participants
n=99 Participants
|
77 participants
n=107 Participants
|
147 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 monthsAn ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Outcome measures
| Measure |
PFC Stockings
n=195 Participants
The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
|
Standard Therapy
n=186 Participants
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
|---|---|---|
|
Number of Participants Who Developed Foot Ulcer During Study Time Frame
|
76 Participants
|
82 Participants
|
Adverse Events
PFC Stockings
Serious events: 30 serious events
Other events: 99 other events
Deaths: 7 deaths
Standard Therapy
Serious events: 16 serious events
Other events: 99 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
PFC Stockings
n=195 participants at risk
The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
|
Standard Therapy
n=186 participants at risk
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
|---|---|---|
|
Infections and infestations
Foot related readmission
|
6.7%
13/195 • Number of events 16
|
3.2%
6/186 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Non-foot related hospitalization
|
8.7%
17/195 • Number of events 22
|
5.4%
10/186 • Number of events 12
|
Other adverse events
| Measure |
PFC Stockings
n=195 participants at risk
The stocking therapy group will be given PFC shear reducing stockings to wear.
PFC Stockings: A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
|
Standard Therapy
n=186 participants at risk
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Standard therapy: Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.51%
1/195
|
2.2%
4/186
|
|
Surgical and medical procedures
Amputation
|
9.2%
18/195
|
4.8%
9/186
|
|
Skin and subcutaneous tissue disorders
New foot ulcer
|
39.0%
76/195
|
44.1%
82/186
|
|
Nervous system disorders
Mechanical fall
|
1.0%
2/195 • Number of events 2
|
1.1%
2/186 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
1.0%
2/195 • Number of events 2
|
1.1%
2/186 • Number of events 2
|
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