Clinical trials: Lower Limb Amputation
Amputation, Diabetes
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain.
- Conditions
- Amputation, Diabetes, Leg Injuries, Traumatic Amputations
- Trial name
- NCT00117793
- Testing
- Total Surface Bearing Suction Socket, Vacuum assisted socket system
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Amputation, Phantom Limb Pain
Neuromodulation in Lower Limb Amputees
The goal of this study is to investigate the role of transcutaneous spinal cord stimulation on spinal cord excitability in lower limb amputees.
- Conditions
- Amputation, Phantom Limb Pain, Hoffman's Reflex
- Trial name
- NCT04543786
- Testing
- Transcutaneous spinal cord stimulation
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Pittsburgh
Lower Limb Amputation, Drop Foot
Evaluating Mobility Interventions in the Real World
This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors.
- Trial name
- NCT04275973
- Testing
- Lower limb prostheses, Orthoses for Drop-foot
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs).
- Trial name
- CP-PRO-01-20 (NCT05392907)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Trauma Injury
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG)…
- Trial name
- NCT04250558
- Testing
- Lower Extremity Amputation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Amputation, Amputation, Traumatic
No Power Bionic Lower Extremity Prosthesis
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
- Trial name
- NCT04070105
- Testing
- Compliant Adaptive Energy Storage and Return Foot, AllPro
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Michigan
Amputation, Prosthesis User
Shared Decision Making Aid for Prosthetic Design
This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.
- Trial name
- D-MAP (NCT04536025)
- Testing
- Qualitative focus group interviews, Qualitative semi-structured interviews
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Colorado, Denver
Amputation, Amputation; Postoperative, Sequelae
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound…
- Conditions
- Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma
- Trial name
- PREVENA-AMP (NCT03773575)
- Testing
- PREVENA™ PEEL & PLACE™ Dressing Kit
- Where
- 3 sites in United States, Italy
- Volunteers
- 272 people
- Sponsor
- Thomas Jefferson University
Lower Extremity Amputation
Community Walking Trials: Comparing Prosthetic Feet
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
- Trial name
- NCT03703232
- Testing
- Investigational prosthetic foot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine