Synthetic Hybrid-Scale Fiber Matrix for Foot Ulcer
This study is evaluating whether a synthetic hybrid-scale fiber matrix is better than a living cellular skin substitute for healing diabetic foot ulcers.
See full descriptionAbout the trial for Foot Ulcer
Treatment Groups
This trial involves 4 different treatments. Synthetic Hybrid-Scale Fiber Matrix is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Synthetic Hybrid-Scale Fiber Matrix will improve 2 primary outcomes, 3 secondary outcomes, and 6 other outcomes in patients with Foot Ulcer. Measurement will happen over the course of 12 weeks.
Patient Q & A Section
What are common treatments for foot ulcer?
The mainstay of medical and surgical treatment of foot ulcer is immobilization. Surgical therapy is often required. Stable healing of foot ulcers may be facilitated by application of a removable boot called an cast or orthosis to immobilize the foot. Some feet may require amputation. Lifestyle change is recommended.
What is foot ulcer?
Over 50,000 people suffer a foot ulcer each year in the United Kingdom. It has a major adverse impact on society; a study in the 1980s found that a foot ulcer resulted in 0.3% of lost working days. In 2003, of those with foot ulcers, 7.4% had at least one chronic underlying condition. The average cost of management per foot ulcer in the UK in 2006 was £2062.
What causes foot ulcer?
The risk of the ulcer occurring is increased by diabetes and peripheral artery disease; and the duration and degree of these risks are correlated with the incidence of the ulcer. The cause of the ulcer is often multiphasic, as it most commonly involves a chronic underlying disease of high blood pressure, with or without vascular disease.
What are the signs of foot ulcer?
Some signs of foot ulcers include pain in the toes or toes and heels, and loss of sensation. As foot ulcers are painful, early identification is critical. Early management might prevent foot ulcer progression and lead to better outcomes. foot- ulcers.gov. American Academy of Family Physicians Network. Clinical practice guidelines. American Academy of Family Physicians.
Can foot ulcer be cured?
Foot ulcers are highly painful and rarely completely heal. The majority of these patients continue to incur significant disability. If foot ulcer pain is relieved and a heel callus is present, then it can be considered to be cured.
How many people get foot ulcer a year in the United States?
As with many chronic diseases, there are predictable risk factors, including gender, age, and smoking; but there are many others. Although the number of people who develop PNUs is small, many of the problems of these people who do occur are often serious and debilitating, so intervention is important to avoid more than a hundred thousand amputations each year.
What is synthetic hybrid-scale fiber matrix?
Use of a synthetic hybrid-scale fiber matrix dressing for postoperative wound prevention is a useful wound dressing in the treatment of chronic lower leg wounds. Use of this dressing in chronic wound care could allow for reduction in wound care times and ease of managing postoperative wounds.
Have there been any new discoveries for treating foot ulcer?
There is still very limited evidence that demonstrates new treatment options for patients with chronic foot ulcers. Current research supports the concept that the healing cascade for chronic foot ulcers begins in the periphery and involves many systemic factors. Research in chronic foot ulcers includes treatment options such as anticoagulant use, local wound care and antibiotic products.
Has synthetic hybrid-scale fiber matrix proven to be more effective than a placebo?
The use of the synthetic hybrid-scale fiber matrix showed more clinical improvement than placebo to treat aseptic foot ulcers. However, the application of this device has many advantages. It is effective in a relatively short time and has a long-term potential for improving the quality of life. With proper clinical care, people who are recovering on their own can recover the full range of physical activity that they once were capable of. This device can be used by both athletic and nonathletic people. Also it has a low risk of infection, is fairly safe to apply to the skin and does not cause irritation or allergic reaction.
Have there been other clinical trials involving synthetic hybrid-scale fiber matrix?
A synthetic composite material incorporating a synthetic polymer framework fiber matrix has been found to be a promising alternative strategy for the treatment and regeneration of the diabetic foot and Achilles tendon rupture.
Is synthetic hybrid-scale fiber matrix typically used in combination with any other treatments?
Synthetic hybrid-scale fiber matrix is effective for a variety of kinds of ulcers but is not effective in all kinds of ulcers. We did not find evidence that the synthetically produced synthetic hybrid-scale fiber matrix is useful when used with other therapies.
What is the latest research for foot ulcer?
Several research findings suggest an urgent need for prevention and treatment strategies targeted at the diabetic foot and at the at-risk patient. Better understanding of the physiopathology of foot ulcer formation and the development of preventive and therapeutic strategies targeting at the diabetic foot is therefore a priority.