9 Clinical Trials for Various Conditions
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including: * angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or * stent placement * atherectomy The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.
Ischemic Foot Ulcer
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor \[HGF\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and offloading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AM product following the protocol and procedures set forth within this document.
Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer, Non-ischemic Diabetic Foot Ulcer
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and off-loading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.
Diabetic Foot Ulcer
The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot amputation
Diabetic Ulcers on Both Feet, Amputation; Traumatic, Limb, Sexual Dysfunction, Diabetic Foot Ulcer Ischemic
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Diabetic Foot Ulcer
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
Critical Limb Ischemia
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.
Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin) and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by subjects at home. Part B will include approximately 3 cohorts in which the concentration of drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in Part B.
Wound Healing