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Amputation clinical trials

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NCT ID: NCT00447655 Completed - Amputation Clinical Trials

Improving Outcomes Following Limb Loss: PALS Plus

PALS-PLUS
Start date: March 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss. Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training. Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss. A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group. Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group. Assessment will be at baseline, treatment completion and six month follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood. Secondary outcome measures are: function, participation and bothersomeness of limitations. The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss. Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities. The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.

NCT ID: NCT00421356 Completed - Amputation Clinical Trials

Comparison of Prosthetic Knee Performance During Sitting and Standing

Start date: January 2007
Phase:
Study type: Observational

The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral amputation to walk up stairs and stand up from sitting. We expect to find that this product has the ability to help unload the sound knee during these tasks. We plan to collect force and motion data while people stand up from a chair. We will compare the data from people using several types of prosthetic knees, including the power knee as well as from people who are not amputees to see what the force and motion contributions are from the different knees evaluated.

NCT ID: NCT00393510 Completed - Diabetic Foot Ulcer Clinical Trials

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Start date: November 2000
Phase: Phase 2
Study type: Interventional

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation. Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

NCT ID: NCT00392028 Withdrawn - Amputation Clinical Trials

Penetration of Ertapenem Into Bone

Start date: November 2006
Phase: N/A
Study type: Interventional

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

NCT ID: NCT00388752 Recruiting - Amputation Clinical Trials

Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation

Start date: September 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.

NCT ID: NCT00383682 Completed - Chronic Pain Clinical Trials

Efficacy of Opioids and Mexiletine for the Treatment of Postamputation Pain

Start date: July 1997
Phase: Phase 2
Study type: Interventional

Persistent pain occurs in 50-85 percent of patients who experience the amputation of an extremity. This study will compare the effectiveness of morphine and mexiletine to placebo in the treatment of postamputation pain. It is hypothesized that the effects of opioids and mexiletine on behavior and mental functioning in patients with postamputation pain are unlikely to be significant barriers to the clinical use of the drugs.

NCT ID: NCT00301444 Recruiting - Pain Clinical Trials

A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

Start date: March 2006
Phase: N/A
Study type: Interventional

The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average intensity of pain, and worst intensity of pain. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (> 3 months) limb amputation. The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.

NCT ID: NCT00271362 Terminated - Inflammation Clinical Trials

Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

Start date: January 2006
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the effect of different lower limb amputation surgical procedures on leg bone integrity and rehabilitation outcome.

NCT ID: NCT00198692 Completed - Depression Clinical Trials

Self-Management Program for Persons With Limb Loss

Start date: August 2003
Phase: N/A
Study type: Interventional

The specific aims of this study are: 1. To develop and pilot a self-management (SM) intervention for persons with limb loss in a group setting using a participatory action research (PAR) strategy. 2. To evaluate the feasiablity and effectiveness of a SM intervention within the context of the existng network of limb loss peer support groups Hypothesis #2a: The SM intervention groups will be more effective than standard support group activities in reducing pain, depression and anxiety, and increasing positive mood and improving function and overall quality of life. Hypothesis #2b: Improvements in pain, depression, anxiety, function and quality of life will correlate strongly with improvements in self-efficacy, catastrophizing, and satisfaction with the prosthesis and prosthetic services. Hypothesis #2c: Gains in outcome will be maintained for one year. Hypothesis #2d: Characteristics of study participants and their environment (i.e. sociodemographics, co-morbidities, economic and educational resources, hope, and social support) will correlate with outcome and mediate the effect of the intervention. 3. To determine the costs of the intervention and examine the relationship between costs and effectiveness. Hypothesis #3a: When compared to the control support group, the SM intervention will be cost-effective in terms of gains in quality adjusted years of life.

NCT ID: NCT00163787 Completed - Amputation Clinical Trials

Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

Start date: June 2003
Phase: N/A
Study type: Observational

All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre or the centre where they received inpatient physiotherapy services. All participants will be tested at discharge and at six months post discharge. Personnel used to score and administer the balance tests at six months will be blinded to pre-test scores, subject background, as well as, mobility and fall history in the six months post discharge. At discharge participants will perform two successful Four Square Step Tests (FSST, and will be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from this TUGT. Participants will also complete the Locomotor Capabilities index (LCI). At the six-month test participants repeat balance and mobility tests and LCI, as well as being interviewed to ascertain fall history since discharge.