October 1, 2025—A groundbreaking new clinical trial combining Cold Atmospheric Plasma (CAP) therapy with infrapopliteal endovascular interventions is set to begin recruitment for patients with diabetic foot ulcers (DFUs) and lower extremity arterial occlusion. Sponsored by Shenyang Medical College and Ansteel Group General Hospital, this randomized, double-blind, placebo-controlled study introduces an innovative approach to address two intertwined complications of diabetes: chronic wounds and arterial blockages. Clinical, quality, and regulatory professionals should take note of this development as it aims to assess the safety and efficacy of a promising medical device technology.
- What is the focus of the trial?
- Who might benefit?
- How will the trial be conducted?
- FAQs
- Key takeaways
- Disclaimer
- Full announcement
What is the focus of the trial?
The trial investigates the efficacy and safety of combining Cold Atmospheric Plasma (CAP) therapy with endovascular intervention for patients with diabetic foot ulcers (DFUs) accompanied by lower extremity arterial occlusion. DFUs are a severe complication of diabetes, often exacerbated by arterial blockages that impair blood flow and hinder the healing process. CAP is a nonthermal plasma technology that has shown potential wound-healing properties, including antimicrobial effects and tissue regeneration. This study is uniquely combining CAP therapy with infrapopliteal endovascular revascularization—a procedure aimed at restoring blood flow to blocked arteries just below the knee.
Who might benefit?
The trial will target diabetic patients with foot ulcers who also have occlusions in lower extremity arteries. These individuals often experience slower wound healing due to impaired circulation. DFUs are associated with high rates of infection, hospitalization, and amputation. Effective, safe interventions are critical to improving patient outcomes and reducing healthcare costs. Combining CAP with standard care and arterial revascularization may offer a more comprehensive solution to these interconnected issues.
How will the trial be conducted?
Researchers will use a randomized, double-blind, placebo-controlled study design. Patients will be assigned to one of the following intervention groups:
- Device group: Cold Atmospheric Plasma (CAP) therapy
- Sham therapy group: Sham CAP therapy as a placebo
- Procedural group: Infrapopliteal endovascular revascularization combined with CAP therapy
- Control group: Standard guideline-based diabetic foot ulcer care
The study will analyze the safety outcomes of the interventions, assess wound healing rates, and determine whether the combined approach improves circulation and tissue regeneration more effectively than traditional care. Regulatory bodies and device manufacturers will observe these results carefully to identify new opportunities for medical device innovation.
FAQ
- What is Cold Atmospheric Plasma (CAP)?
CAP is an ionized gas that operates at room temperature. It has antimicrobial and tissue-regenerating properties, making it promising for wound care. - What is infrapopliteal endovascular revascularization?
This procedure restores blood flow in arteries below the knee using minimally invasive techniques, often involving stents or balloon angioplasty. - Who is conducting the study?
The trial is sponsored by Shenyang Medical College and Ansteel Group General Hospital. - When will recruitment begin?
As of now, recruitment is labeled “Not yet recruiting.” Further details will be announced as scheduling progresses. - How can I access more details?
All trial details, including eligibility criteria, are listed on ClinicalTrials.gov.
Key takeaways
This upcoming trial represents a vital exploration of combining novel medical device technology with procedural interventions to tackle diabetic foot ulcers complicated by arterial occlusion. Regulatory stakeholders and clinical teams should monitor this study to evaluate its potential impact on DFU treatment protocols. The results may shape future device development and clinical practice.
Disclaimer
This content is intended for informational purposes for professionals. It does not constitute legal or clinical advice. Readers must refer to regulatory guidelines and official trial documentation.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07198061?term=medical+device