Therapeutic Stockings to Prevent Foot Ulcers

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01221194
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 381
• Locations: 4
• Arms: 2
• Duration (Months): 65
• Patients Per Site: 95.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.

2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Behavioral: Standard therapy; Device: PFC Stockings	N/A

Detailed Description

We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Therapeutic Stockings to Prevent Foot Ulcers
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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.
Active Comparator: PFC Stockings The stocking therapy group will be given PFC shear reducing stockings to wear.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Developed Foot Ulcer During Study Time Frame [30 months]

   An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men or women 18 years old or older

• Diagnosis of Diabetes Mellitus*

• History of diabetes related foot ulceration

Spanish-speaking subjects will be eligible to participate.

Exclusion Criteria:

• Active Charcot Arthropathy

• Gangrene, active infection

• Midfoot or higher level amputation

• Alcohol or substance abuse within 6 months

• Unreliable, unwilling or unable to comprehend informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Health & Hospital Systems	Dallas	Texas	United States	75235
2	UT Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390
3	Scott & White	Temple	Texas	United States	76502
4	University of Manchester	Manchester		United Kingdom

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Lawrence Lavery, DPM, UT Southwestern Medical Center at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Larry Lavery, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01221194
• Other Study ID Numbers: STU 082010-090
• First Posted: Oct 14, 2010
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Larry Lavery, Professor, University of Texas Southwestern Medical Center: diabetes; foot ulcer prevention; therapeutic stockings
• Additional relevant MeSH terms: Foot Ulcer

Study Results

Participant Flow

Arm/Group Title	PFC Stockings	Standard Therapy
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	195	186
COMPLETED	195	186
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PFC Stockings	Standard Therapy	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	195	186	381
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.06 (11.14)	56.08 (6.76)	53.72 (9.64)
Sex: Female, Male (Count of Participants)
Female	51 26.2%	43 23.1%	94 24.7%
Male	144 73.8%	143 76.9%	287 75.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	56 28.7%	42 22.6%	98 25.7%
Not Hispanic or Latino	133 68.2%	136 73.1%	269 70.6%
Unknown or Not Reported	6 3.1%	8 4.3%	14 3.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 3.1%	13 7%	19 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	17 8.7%	23 12.4%	40 10.5%
White	166 85.1%	144 77.4%	310 81.4%
More than one race	2 1%	3 1.6%	5 1.3%
Unknown or Not Reported	4 2.1%	3 1.6%	7 1.8%
Region of Enrollment (participants) [Number]
United States	125 64.1%	109 58.6%	234 61.4%
United Kingdom	70 35.9%	77 41.4%	147 38.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Developed Foot Ulcer During Study Time Frame
Description	An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Time Frame	30 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PFC Stockings	Standard Therapy
Arm/Group Description	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 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.
Measure Participants	195	186
Count of Participants [Participants]	76 39%	82 44.1%

Adverse Events

Arm/Group Title	PFC Stockings		Standard Therapy
Arm/Group Description	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 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.
All Cause Mortality
	PFC Stockings		Standard Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/195 (3.6%)		7/186 (3.8%)
Serious Adverse Events
	PFC Stockings		Standard Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/195 (15.4%)		16/186 (8.6%)
Infections and infestations
Foot related readmission	13/195 (6.7%)	16	6/186 (3.2%)	7
Musculoskeletal and connective tissue disorders
Non-foot related hospitalization	17/195 (8.7%)	22	10/186 (5.4%)	12
Other (Not Including Serious) Adverse Events
	PFC Stockings		Standard Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	99/195 (50.8%)		99/186 (53.2%)
Infections and infestations
Osteomyelitis	1/195 (0.5%)		4/186 (2.2%)
Musculoskeletal and connective tissue disorders
Foot fracture	2/195 (1%)	2	2/186 (1.1%)	2
Nervous system disorders
Mechanical fall	2/195 (1%)	2	2/186 (1.1%)	2
Skin and subcutaneous tissue disorders
New foot ulcer	76/195 (39%)		82/186 (44.1%)
Surgical and medical procedures
Amputation	18/195 (9.2%)		9/186 (4.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.