Feasibility Study Shows High Wound Closure Rates in Chronic Diabetic Ulcers

Patients with chronic diabetic foot and leg ulcers that had failed standard care reported rapid microbe reduction, high wound closure rates, and avoidance of amputation across 2 prospective cohorts, according to one study.¹

This feasibility study is published in the Journal of Tissue Repair and Regeneration.

It provides early-stage data on the Hemastyl System, a novel therapeutic approach designed to restore nerve signaling and support tissue healing in chronic, infected, nonhealing wounds. The study highlights both clinical and functional outcomes in patients who had previously shown minimal response to standard care.

“Neuropathy has long been treated as an endpoint—something clinicians manage around rather than address directly,” said Margaret Kalmeta, inventor and founder of Rapid Nexus Nanotech Wound Solutions, Inc, in a statement.² “This study suggests that when nerve signaling is restored, the body may regain the ability to stabilize and heal tissue that would otherwise be lost. That represents a fundamental shift in how we think about recovery in advanced disease.”

Diabetic foot ulcers are a common and serious complication of poorly controlled diabetes mellitus, most often arising from a combination of peripheral neuropathy, peripheral arterial disease, and impaired wound healing, and they are a leading cause of nontraumatic lower‑limb amputation in the US, according to the NIH.³ It is estimated that up to 15% to 25% of individuals with diabetes will develop a foot ulcer in their lifetime, and these ulcers frequently occur in weight‑bearing areas due to loss of protective sensation and repetitive trauma.³

Two prospective feasibility cohorts were conducted in Costa Rica to evaluate the Hemastyl System in patients with chronic, infected diabetic nonhealing wounds.¹ Patients were enrolled prospectively and treated under local regulatory frameworks applicable to non–FDA-regulated feasibility research. A total of 39 patients with wounds unresponsive to standard care for at least 3 months were included across both cohorts. Wounds varied in duration from 2 to 40 years, representing a wide range of chronicity and severity. Clinician examinations occurred approximately 3 times per week, and outcome measures included wound closure, microbe reduction, periwound recovery, subjective neuropathy improvement, and avoidance of amputation. The study design allowed frequent monitoring to capture early and sustained changes in wound and sensory outcomes.

In the first cohort (n = 17), patients with Wagner grade 2–4 wounds treated with the Hemastyl System experienced microbe reduction within 1 to 2 days, with a wound closure rate of 99%. Five patients reported restored warmth, 4 patients regained sensation, and 6 patients reported increased sensation. All patients previously diagnosed for potential amputation avoided surgery, indicating a complete prevention of surgical intervention in this high-risk subgroup.

In the second cohort (n = 22), microbe reduction occurred within 1 to 2 days, and the wound closure rate was 97%. Three patients reported restored warmth, 2 regained sensation, and 13 reported increased sensation. All patients with prior amputation diagnoses avoided surgical intervention. The cohort demonstrated consistent early microbial control and progressive functional recovery comparable to the first cohort, supporting reproducibility across different patient groups.

In combined analysis (n = 39), the average wound closure rate was 98%, and all 19 patients previously diagnosed for potential amputation successfully avoided surgery. These results demonstrate consistent outcomes across both cohorts, with rapid microbial control, high closure rates, and functional improvements in sensation and warmth.

The researchers acknowledged several limitations. First, the study was early-stage feasibility research and not a randomized controlled trial. Second, it was conducted under Costa Rican regulatory frameworks and did not require formal institutional review board approval. Cohort sizes were small, and the absence of a control group limits comparison with standard care outcomes. Additionally, wound durations varied widely, which may have influenced the consistency of results and limits generalizability to broader populations.

Despite these limitations, the feasibility studies demonstrate rapid microbe reduction, high wound closure rates, subjective improvements in periwound warmth and sensation, and complete avoidance of amputation among high-risk patients with chronic, infected diabetic ulcers unresponsive to standard care. The combined outcomes provide early evidence supporting the Hemastyl System’s potential effectiveness in these complex wounds.

“Subjective reports of restored warmth and sensation suggest improvement in vascular and neural function, consistent with the system’s intended mechanism of action,” wrote the researchers of the study. “These findings support the importance of addressing neuropathy and vascular compromise alongside microbial burden.”

References

1. Kalmeta M. Diabetic Foot and Leg Ulcer & Peri-wound Neuropathy Healing Feasibility Studies. Journal of Tissue Repair and Regeneration. 2026;1(2):37-45. doi:10.14302/issn.2640-6403.jtrr-25-5922.
2. First peer-reviewed study shows tissue once deemed nonsalvgeable can be healed in patients facing amputation. News release. Rapid Nexus. January 20, 2026. Accessed February 5, 2026. https://finance.yahoo.com/news/first-peer-reviewed-study-shows-135500194
3. Oliver TI, Mutluoglu M. Diabetic Foot Ulcer (Archived). 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 30726013