CLINICAL TRIAL

Synthetic Hybrid-Scale Fiber Matrix for Foot Ulcer

Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether a synthetic hybrid-scale fiber matrix is better than a living cellular skin substitute for healing diabetic foot ulcers.

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About the trial for Foot Ulcer

Eligible Conditions
Diabetic Foot · Ulcer · Varicose Ulcer · Diabetic Foot Ulcers (DFUs) · Venous Leg Ulcer (VLU) · Foot Ulcer · Leg 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.

Experimental Group 1
Synthetic Hybrid-Scale Fiber Matrix
DEVICE
Experimental Group 2
Synthetic Hybrid-Scale Fiber Matrix
DEVICE
Control Group 3
Lyophilized Acellular Fish Skin
DEVICE
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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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The wound size must be at least 1.0 cm^2 and no more than 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement. show original
and ≤ 0.9 were all classified as “normal.” The dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5 and ≤ 0.9 were all classified as “normal” by the study. show original
You must be at least 18 years old to participate. show original
The participant is willing and able to comply with all the requirements of the study. show original
The participant or legal representative is willing to provide written consent. show original
A person with diabetes has a disorder in which their body does not produce or properly use insulin. show original
to be classified as a plantar foot ulcer show original
A person must have an ulcer for more than 28 days prior to being enrolled in the study, and the ulcer has not healed with standard treatment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to six months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to six months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to six months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
12 WEEKS
100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
12 WEEKS
For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
16 WEEKS
100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
16 WEEKS
Pain Reported By Participant
DAY OF INITIAL PRODUCT APPLICATION AND AT EITHER 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS) OR AT 100 PERCENT EPITHELIALIZATION (WHICHEVER OCCURS FIRST)
The pain reported by the participant on a scale of 0 through 10 with 10 being the highest level of pain the participant has experienced
DAY OF INITIAL PRODUCT APPLICATION AND AT EITHER 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS) OR AT 100 PERCENT EPITHELIALIZATION (WHICHEVER OCCURS FIRST)
Score on SF-36 Questionnaire Measuring Quality of Life
DAY OF INITIAL PRODUCT APPLICATION AND AT EITHER 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS) OR AT 100 PERCENT EPITHELIALIZATION (WHICHEVER OCCURS FIRST)
DAY OF INITIAL PRODUCT APPLICATION AND AT EITHER 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS) OR AT 100 PERCENT EPITHELIALIZATION (WHICHEVER OCCURS FIRST)
Decrease in Wound Area
WEEKLY ASSESSMENTS FOR 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS), OR UNTIL 100 PERCENT EPITHELIALIZATION, WHICHEVER OCCURS FIRST.
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.
WEEKLY ASSESSMENTS FOR 12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS), OR UNTIL 100 PERCENT EPITHELIALIZATION, WHICHEVER OCCURS FIRST.
Time to 100 Percent Epithelialization
12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS), OR UNTIL 100 PERCENT EPITHELIALIZATION, WHICHEVER OCCURS FIRST.
The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
12 WEEKS FOR DFU PARTICIPANTS (16 WEEKS FOR VLU PARTICIPANTS), OR UNTIL 100 PERCENT EPITHELIALIZATION, WHICHEVER OCCURS FIRST.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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