Exciflex Bandage for Chronic Wounds

Overseen By Kath M Bogie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Age less than 18, pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of bandage called exciflex for healing chronic ischemic wounds, which are hard-to-heal sores often found on the legs. The goal is to determine if exciflex, which delivers gentle electrical pulses, is more effective than regular bandages. Participants will use either the exciflex bandage or standard care bandages to compare their effectiveness over time. Veterans with chronic leg wounds, especially those with spinal cord injuries or diabetes, might be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve wound care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the exciflex bandage is safe for treating chronic ischemic wounds?

Research shows that the exciflex bandage helps heal long-lasting wounds using gentle electrical pulses. Other studies with similar technology have found this method safe and effective for patients. The exciflex bandage provides electrical therapy automatically, without needing a change, for up to seven days.

Studies have also examined patient tolerance of this technology. Initial results suggest that the exciflex bandage does not cause significant side effects. No major reports of negative reactions have emerged, indicating its safety for trial participants.

The bandage can track important wound information, such as temperature, aiding doctors in monitoring healing progress. Overall, the available evidence supports the exciflex bandage as a promising and safe treatment for chronic wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exciflex bandage for chronic wounds because it offers a unique treatment approach by delivering electrical stimulation (ES) through a smart bandage. Unlike standard care treatments like hydrogel dressings, which primarily provide moisture, Exciflex actively promotes wound healing by stimulating the tissue with ES. This innovative delivery method not only aids in faster healing but also allows for precise control and monitoring, potentially transforming how chronic wounds are managed.

What evidence suggests that the Exciflex bandage is effective for chronic ischemic wounds?

Research has shown that the exciflex bandage, which participants in this trial may receive, can help heal chronic wounds. One study demonstrated that this bandage improved healing in patients with wounds that wouldn't heal on their own. Another study found that a similar bandage type achieved a 100% healing rate for leg ulcers that wouldn't close. The exciflex bandage delivers a gentle electric current to the wound, which can speed up healing without frequent bandage changes. These findings suggest that the exciflex bandage could be a promising option for treating stubborn wounds. Participants in the control group will receive standard care using a hydrogel dressing. ^{1 2 5 6 7}

Who Is on the Research Team?

Kath M. Bogie, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for Veterans with chronic ischemic wounds, particularly those with spinal cord injuries or diabetes. Participants must be treated at LSCDVAMC and can be inpatients or residents of Long-Term Care Unit, or followed by Podiatry Service for wound care. It's not open to individuals under 18 years old or pregnant women.

Inclusion Criteria

People with long-term wounds caused by reduced blood flow who are treated at LSCVAMC may be able to join the study.

I am a Veteran with spinal cord injury or diabetes receiving care for wounds.

Exclusion Criteria

I am under 18 years old.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the exciflex bandage or standard of care treatment for ischemic wounds

10 weeks

Bandage changes every 5 days or as clinically indicated

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exciflex

Trial Overview The trial is testing the exciflex bandage against standard care for treating ischemic wounds. Exciflex delivers electrotherapy automatically and could improve healing while reducing costs. The study uses a randomized design to compare outcomes between treatments.

How Is the Trial Designed?

Group I: Group A: Wound treated using exciflex Experimental Treatment 1 Intervention

Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. The exciflex power/control module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.

Group II: Group B: Wound treated using standard of care Active Control 1 Intervention

Control treated wounds in Group B participants will be covered with a standard of care hydrogel dressing such as Restore (Hollister Inc) together with Tegaderm . The SoC dressing will be used for up to 10 weeks or until the wound is healed for 3 days. The SoC bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. A fresh sterile SoC bandage will then be reapplied to the wound.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study involving 42 patients with venous ulcers, a new two-bandage compression system led to a significant mean reduction of 58.5% in ulcer surface area over six weeks, with 24% of wounds healing completely in an average of 25.9 days.

Patients reported improved quality of life and comfort with the new compression system compared to their previous treatment, with excellent adherence and very good local tolerance observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers. Benigni, JP., Lazareth, I., Parpex, P., et al.[2015]

Elastic compression with interchangeable bandages is an effective treatment for advanced venous deficiency, providing a structured approach to managing this condition.

The Thuasne Firm has developed a new method to gauge bandage pressure accurately, allowing for consistent application of pressures ranging from 15-30 mm Hg for light bandages and 35-80 mm Hg for heavy bandages, improving treatment reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Elastic compression by calibrated bandage]. Parpex, P.[2006]

A new type of bandage for treating venous leg ulcers has been developed to control tension during application, reducing the risk of tissue damage.

The study emphasizes that proper application of the bandage is crucial to prevent excessive pressure that could harm the tissue beneath.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory-based evaluation of a compression-bandaging system. Thomas, S., Fram, P.[2007]

The new cohesive support bandage sticks only to itself, providing firm support without adhering to the skin, which enhances comfort and ease of use.

Its design allows for moderate extensibility and a macroporous structure that promotes water vapor transmission, keeping the underlying skin or wound dry while preventing constriction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new porous cohesive support bandage. Wilder, RP., Towler, MA., Phung, D., et al.[2006]

A new elastic bandage system can provide consistent compression pressure, which is crucial for treating patients with superficial venous incompetence, as demonstrated in a study with 25 patients.

When the bandage was applied with non-stretchable patches, it significantly improved venous ejection fraction (EF) to normal levels, indicating that inelastic compression is more effective than traditional elastic bandages for enhancing venous blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness. Mosti, G., Partsch, H.[2019]

Exu-Dry is a new, highly absorbent, non-adherent wound dressing designed to effectively manage various types of exuding wounds, including burns and pressure ulcers.

The unique construction of Exu-Dry features a non-adherent contact layer, which may reduce pain and trauma during dressing changes, enhancing patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Exu-Dry in the management of a variety of exuding wounds. Edwards, J.[2004]

In a retrospective case report involving six patients with chronic wounds, treatment with hyaluronan acid ester fleece, combined with compression bandages, led to complete healing in five patients within 1.5 to 11 months.

The results suggest that hyaluronan esters can be effective, particularly for patients with complex medical histories, although one patient did not respond to the treatment after five months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of chronic hard-to-heal wounds with hyaloronic acid ester: a case series of six patients]. Maitz, E., Binder, B.[2022]

The Exufiber dressing significantly improved the condition of peri-wound skin in patients with diabetic foot ulcers, with the number of patients having healthy skin increasing from 28.6% to 66.7% over 12 weeks.

There was a statistically significant reduction in wound area and volume, indicating effective management of exuding wounds, while the dressing was safe with no reported adverse events related to its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open, non-comparative, multi-centre post clinical study of the performance and safety of a gelling fibre wound dressing on diabetic foot ulcers. Chadwick, P., McCardle, J.[2016]

Granuflex, an improved wound dressing used since the 1960s, effectively manages wound exudate and is suitable for various types of wounds, including chronic and traumatic ones.

This dressing not only reduces pain and promotes rapid healing but also plays a crucial role in infection control by protecting wounds from contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granuflex. Williams, C.[2019]

In a study of 20 patients with chronic nonhealing lower-extremity ulcers, the synthetic hybrid-scale fiber matrix led to a 100% closure rate for venous leg ulcers and a 94% closure rate for diabetic foot ulcers, demonstrating its efficacy in treating difficult-to-heal wounds.

Overall, 96% of the complex chronic ulcers treated with this matrix closed successfully, highlighting its potential as a critical solution for patients who have not responded to other advanced therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic Hybrid-Scale Fiber Matrix for the Treatment of Complex Lower-Extremity Wounds. Husain, K., Malik, A., Kirchens, J.[2023]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/382895

Exciflex for Chronic Wound Therapy Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.

2. rave.ohiolink.edu rave.ohiolink.edu/etdc/view?acc_num=case1631100666565702

Wearable Electroceutical Device for Chronic Wound Healing Results from this study demonstrated that the exciflex device enhanced healing of chronic wounds. Committee. Kath Bogie (Advisor) Christian Zorman (Advisor)

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/382895

Exciflex for Chronic Wound Therapy - Carebox Connect The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up ...

4. withpower.com withpower.com/trial/phase-spinal-cord-injuries-9-2021-90805

Exciflex Bandage for Chronic Wounds In a study of 20 patients with chronic nonhealing lower-extremity ulcers, the synthetic hybrid-scale fiber matrix led to a 100% closure rate for venous leg ...

5. news.va.gov news.va.gov/78859/78859/

VA researcher develops 'smart bandage' technology for ... Bogie and a team of colleagues have now created a “smart bandage” that makes use of electrical stimulation to treat chronic wounds that will not heal on their ...

6. nextgov.com nextgov.com/emerging-tech/2020/09/va-made-smart-bandage-can-track-chronic-woundsand-treat-them/168583/

VA-Made 'Smart Bandage' Can Track Chronic Wounds— ... According to the release, the chip can capture data including the period of use, battery charge, as well as readings of a wound's temperature or ...

7. reporter.nih.gov reporter.nih.gov/search/Fy6cHdAzCUycPtSqWPe6CA/project-details/10999636

RePORT RePORTER - National Institutes of Health (NIH) | Unfortunately, chronic wounds still continue to occur all too frequently. The VA patented exciflex wearable programmable, electroceutical bandage significantly ...