Edema Leg Clinical Trial
— EMPAROfficial title:
Comparison of Wound Healing, Edema Level, Knee Range of Motion, Protection Post Falls, Device Application, Time to Prosthetic Fit, and Cost Between Postoperative Soft Dressing and Vacuum Removable Rigid Dressing After Transtibial Amputation
NCT number | NCT03948087 |
Other study ID # | EMPAR |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2019 |
Est. completion date | May 2021 |
Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 2021 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Transtibial amputation related to peripheral vascular disease with or without diabetes or trauma. Justification: The form and function of the ORD device relates solely to transtibial amputees. The device is not useable for any other limb amputation type (e.g. transfemoral, transmetatarsal). The choice of using vascular compromised participants is intentional. Ischemia and necrosis rapidly ensue as a result of vessel occlusion which can easily happen with any external compressive force (e.g. tensor bandaging). The ORD does not apply compressive force to the residual limb. 2. Transtibial amputation that includes myodesis and/or myoplasty. Justification: Myoplasty and myodesis are preferred surgical techniques while performing an amputation. They involve the surgical attachment of muscle to muscle (myoplasty) or muscle to bone (myodesis) across the end of the residual limb prior to skin flap closure. This allows increased stability and provides a better interface with a future prosthetic device. 3. Greater than 18 years of age Justification: Below the age of 18 informed consent must be obtained by a parent or guardian 4. Patient must be able to speak and understand English in order to provide informed consent. No reliance on translator services will be implemented. 5. Has no major illness where life expectancy is less than 2 years. Justification: This is the study timeline and co-morbidities that limit participation within this timeframe will introduce confounding factors. Exclusion Criteria: 1. Severe dementia or insufficient cognition. Justification: Inability to provide informed consent to participate in the study. 2. Knee contracture greater than 30 degrees Justification: The ORD will not fit a limb with too much flexion at the knee. Wound healing is also affected due to pressure across the end of the residual limb without the use of offloading techniques. 3. Severe peripheral vascular disease involving the contralateral lower limb Justification: Having severe peripheral vascular disease to the contralateral limb may affect the secondary outcome measures due to the need for further medical or surgical intervention. 4. Inability to speak, read, or understand English. Justification: For a patient to participate in the study informed consent must be obtained. There is a high probability that there would be too much variability among translators (family member or institutional) to ensure consistent informed consent. 5. Neurological condition or medical disorder that could affect rehabilitation. Justification: Rehabilitation post transtibial amputation is critical to overall functional outcomes as well as study outcomes. If a patient has difficulty with participation in rehabilitation then this will be a confounding factor. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Covenant Health | Alberta Innovates Health Solutions |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Change in Stump Wound Healing | The Photographic Wound Assessment Tool (PWAT) will be used in a blinded fashion to evaluate the level of change in wound healing of the transtibial amputation primary closure. The PWAT incorporates type and amount of necrotic tissue, wound edge definition, surrounding skin color, epithelialization, and granulation of tissue. A score of 0/24 on the PWAT indicates complete wound closure. | Day 3,7,14,30,48 | |
Secondary | Evaluation of Change in Level of Limb Edema | Circumferential measurements will be taken at two levels of the residual stump. Centimeters measured circumferentially at 5 cm from the distal end and around the knee at the center of the patella | Day 3,7,14,30,48 | |
Secondary | Evaluation of Change in Knee Range of Motion | Degrees measured via goniometry into knee flexion and extension for both active and passive range of motion. | Day 3,7,14,30,48 | |
Secondary | Rate of Revision Post Falls | Falls sustained by study participants will be recorded. Whether a follow-up revision surgery was necessary will also be recorded. | Until prosthetic limb fit, on average 2 months. | |
Secondary | Total Amount of Time to Apply, Change, Clean and Alter the Dressings | Time log in minutes recorded by staff in real time providing care to study participants. | Until discharge from acute care, on average 2 weeks. | |
Secondary | Length of time Until the Residual Limb is Ready for Prosthetic Fitting | Time log in days beginning post operative day 1 until the study participant is fit with a definitive prosthetic limb. | Through study completion, on average 2 months. | |
Secondary | Total Length of Stay in Acute and Sub-acute Care Facilities | A time log in days of how long a given study participant is admitted to an acute or sub-acute care facility. | Through study completion, on average 3 weeks. |
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