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

Trial Summary

What is the purpose of this trial?

Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds. Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use. Methodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy. Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.

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 data supports the effectiveness of the treatment Exciflex for chronic wounds?

The research on similar treatments like Exufiber and Granuflex shows that these types of dressings can help manage chronic wounds by controlling wound fluid, reducing pain, and promoting healing. Additionally, treatments with hyaluronan acid esters have shown good results in healing chronic wounds, suggesting that components similar to those in Exciflex may be effective. ^{1 2 3 4 5}

How is the Exciflex treatment for chronic wounds different from other treatments?

Exciflex bandage is unique because it is designed to provide consistent compression pressure, which is independent of the healthcare provider's application technique and the size of the limb. This ensures a more reliable and manageable treatment for chronic wounds compared to traditional bandages that can vary in pressure. ^{6 7 8 9 10}

Research Team

Kath M. Bogie, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

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

Pregnancy

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Synthetic Hybrid-Scale Fiber Matrix for the Treatment of Complex Lower-Extremity Wounds. [2023]

2. Austria pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Granuflex. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2016]

6. England 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. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Elastic compression by calibrated bandage]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Laboratory-based evaluation of a compression-bandaging system. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

A new porous cohesive support bandage. [2006]