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Residual Limbs clinical trials

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NCT ID: NCT05749952 Completed - Amputation Clinical Trials

Digital Weight Bearing Shape Capture Socket Technology

DWB
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

NCT ID: NCT05501444 Completed - Hyperhidrosis Clinical Trials

Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

Start date: August 9, 2022
Phase: N/A
Study type: Interventional

The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.

NCT ID: NCT05344261 Withdrawn - Amputation Clinical Trials

Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

NCT ID: NCT03484429 Completed - Chronic Pain Clinical Trials

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

NCT ID: NCT03433859 Completed - Hyperhidrosis Clinical Trials

Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

SALUTOX
Start date: March 2016
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

NCT ID: NCT03255395 Recruiting - Amputation Clinical Trials

Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain

Start date: April 24, 2017
Phase: N/A
Study type: Interventional

AIM: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain. PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic (>3 months) phantom/residual limb pain (NPS ≥ 4). DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures. After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; the patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected. Relevant cost data will be collected in order to enable an assessment of the total cost of the procedure.