Clinical trials: Lower Extremity Surgical Amputation
Diabetic Foot, Infections
Toe Amputations in Patients With Diabetes
This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left…
- Conditions
- Diabetic Foot, Infections, Amputation
- Trial name
- PANDORAT (NCT05855980)
- Testing
- Wound closure
- Where
- Finland
- Volunteers
- 102 people
- Sponsor
- Tampere University Hospital
Critical Limb Ischemia
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.
- Trial name
- BEST-CLI (NCT02060630)
- Testing
- Open surgical revascularization, Endovascular revascularization
- Where
- 161 sites in United States, Canada and 3 more
- Volunteers
- 1,843 people
- Sponsor
- Carelon Research
Extremity Lower Wounds
Wound Necrosis in Lower Extremity Surgery
Researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.
- Trial name
- NCT03351387
- Testing
- SPY Intra-operative Angiography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Perineural, Methylene Blue
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role…
- Conditions
- Perineural, Methylene Blue, Lower Limb Amputation
- Trial name
- NCT05830630
- Testing
- Bupivacaine methylene blue, bupivacaine saline
- Where
- Egypt
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Tanta University
Wound Infection, Amputation Wound
The Amputation Surgical Site Infection Trial (ASSIT)
Lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or, infection.
- Trial name
- ASSIT (NCT02018094)
- Testing
- Co-amoxiclav, Iodine, Metronidazole
- Where
- United Kingdom
- Volunteers
- 160 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Phantom Limb, Residual Limb Pain
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
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.
- Conditions
- Phantom Limb, Residual Limb Pain, Traumatic Amputation, Amputation
- Trial name
- NCT00388752
- Testing
- Acupuncture
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Walter Reed Army Medical Center
Amputation Stumps
The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine
The use of clonidine as an alternative to epidural opioids offers several potential benefits. Clonidine does not have respiratory depressant effects, and the incidence of vomiting and pruritus is less frequent compared with that…
- Trial name
- NCT02128451
- Testing
- Meperdine, Fentanyl
- Where
- 2 sites in Egypt
- Volunteers
- 90 people
- Sponsor
- Tanta University
Amputation, Surgical, Phantom Limb Pain
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy)…
- Conditions
- Amputation, Surgical, Phantom Limb Pain, Neuroma Amputation, Surgery
- Trial name
- PreventPAP (NCT06719245)
- Testing
- Targeted Muscle Reinnervation (TMR), Standard neurectomy
- Where
- 7 sites in Netherlands
- Volunteers
- 203 people
- Sponsor
- Leiden University Medical Center
Surgical Wound, Wound Heal
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
- Conditions
- Surgical Wound, Wound Heal, Amputation
- Trial name
- NCT03250442
- Testing
- PrevenaTM Device, Standard Dry Dressing
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Georgetown University
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
Wound Heal, Wound Dehiscence
CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C.
- Trial name
- CiNPWT (NCT06493539)
- Testing
- Standard of Care group, CINPWT
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Southern California
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
Amputation, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
Amputation; Traumatic, Leg, Lower
Transtibial Osseointegration
Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members.
- Trial name
- TOSS (NCT06636136)
- Testing
- OPRA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Walter Reed National Military Medical Center
Acute Ischemia of Lower Limb
Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
Study of acute lower ischemia therapies based on data collected from the Swedish Vascular Surgery Registry between 1994 and 2014.
- Trial name
- NCT02835027
- Testing
- Open versus endovascular surgery
- Volunteers
- 16,287 people
- Sponsor
- Uppsala University Hospital
Anesthesia, Amputation; Traumatic, Leg, Lower
Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS)
Major lower limb amputation is recognised as a significant cause of morbidity and mortality. In the United Kingdom, 30-day in-hospital mortality is up to 8.7%.
- Trial name
- ATLLAS (NCT07244627)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
Foot Ulcers, Osteomyelitis
Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients
To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.
- Conditions
- Foot Ulcers, Osteomyelitis, Amputation
- Trial name
- HSI (NCT03787862)
- Where
- 2 sites in United States
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
Vascular Surgical Procedures
Pain Management of Amputation Wounds With AutoHypnosis
Amputation in vascular surgery mainly concerns the lower limb and is often linked to Obliterative Arterial Disease of the Lower Limbs.
- Trial name
- MODOUPAAH (NCT05779852)
- Testing
- self-hypnosis and dressing, dressing
- Where
- France
- Volunteers
- 44 people
- Sponsor
- Rennes University Hospital