Effects of Shrinker Use on Healing and Volume

NCT ID: NCT00693628

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-01-31

Brief Summary

We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".

Detailed Description

Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Conditions

Transtibial Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shrinker

Patients receive 20-30 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.

Group Type: ACTIVE_COMPARATOR

compression shrinker

Intervention Type: DEVICE

Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker

No Shrinker

Control group - participants will not receive an intervention (compression shrinker).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Shrinker 2

Patients receive 30-40 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.

Group Type: ACTIVE_COMPARATOR

compression shrinker

Intervention Type: DEVICE

Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker

Interventions

compression shrinker

Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker

Intervention Type: DEVICE

Other Intervention Names

Juzo® Compression Therapy Garment

Eligibility Criteria

Inclusion Criteria

• Recently undergone primary transtibial amputation
• Patients between ages of 18 and 100 years of age

Exclusion Criteria

• Undergone previous amputations above the Symes level

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Day, BSPO

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics

Locations

University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

13310

Identifier Type: OTHER

Identifier Source: secondary_id

13310

Identifier Type: -

Identifier Source: org_study_id