Clinical Evaluation of a Novel Synthetic Nanofiber Wound Matrix for the Treatment of Chronic Wounds

ABSTRACT

Chronic wounds, including Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs) and Pressure Ulcers (PUs), present significant challenges for the patients, clinicians and healthcare systems. There remains a strong need for novel and effective technologies to accelerate the healing of these wounds. The objective of this prospective, single‐arm pilot study was to evaluate the clinical performance of a novel nanofiber wound matrix for the treatment of chronic lower extremity wounds refractory to standard‐of‐care treatment at a single centre. A total of 15 patients with 15 chronic wounds (5 DFUs, 8 VLUs and 2 PUs) were included in this study. These wounds were non‐healing to previous standard‐of‐care treatments for an average of 4 weeks. They were all treated with the novel nanofiber wound matrix with weekly clinical evaluation and re‐application for a total duration of four (4) weeks, per the study protocol. The average wound area reduction (WAR) was 83.6% upon 4 weeks of treatment with the application of the subject wound matrix, as an adjunctive measure to the standard of care. Additionally, seven (7) of the 15 wounds (46.7%) completely healed starting from Week 3, and the average complete healing time was 13.9 days. These results demonstrated accelerated healing effects of the subject wound matrix, when compared to the standard of care reported in literature, where the average WAR was at 62.9% at Week 12, six (6) of the 18 wounds (33.3%) were completely healed within 12 weeks, and the average complete healing time was 49.0 days. These results demonstrated that the subject wound matrix is a safe and effective novel technology in treating chronic wounds, providing significant clinical and economic benefits for patients with various chronic wounds.

Key Points

• This prospective, single‐centre, single‐arm pilot study evaluated a novel synthetic absorbable nanofiber wound matrix in 15 chronic lower‐extremity wounds, including diabetic foot ulcers, venous leg ulcers, and pressure ulcers, that had failed to heal after at least 4 weeks of standard‐of‐care treatment.

• In this refractory chronic wound cohort, adjunctive treatment with the nanofiber wound matrix was associated with substantial early healing, with a mean wound area reduction of 83.6% at week 4.

• Complete wound closure was achieved in 7 of 15 wounds (46.7%) from week 3 onward, and the mean time to complete healing among healed wounds was 13.86 days.

• Favorable healing outcomes were observed across multiple chronic wound types, while no adverse events, serious adverse events, wound infections, device‐related complications, or device malfunctions were reported during the 4‐week treatment period.

• These preliminary findings support the potential clinical utility of this novel synthetic nanofiber wound matrix as an adjunct to standard care and justify further evaluation in larger, controlled studies.

1. Introduction

Chronic wounds, including Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs) and Pressure Ulcers (PUs), are causing a significant burden for patients, wound care professionals and healthcare systems [1]. Chronic wounds do not heal through the standard physiological wound healing process; instead, they persist for an average of 12 to 13 months, typically stalled in a prolonged inflammatory state [1]. The chronic wounds also may recur after healing [1]. As a result, chronic wounds significantly decrease the quality of life of patients. Recent analysis showed that the 5‐year mortality rate and costs for treating the DFUs are close to those in most cancers and even higher than those in breast cancer and prostate cancer [2]. Despite the recent advancements in diabetes management in the US, the incidence of DFUs is still rising, driving the DFU‐related amputation rates rising over the last 10 years [3].

Standard wound care treatment can include debridement, offloading, application of advanced wound dressings and negative pressure therapies [4]. Because these wounds are stuck in a chronic inflammatory state, they are often difficult to heal and patients often fail to respond to these standard therapies. Specifically, the advanced wound dressings, such as foam dressing, alginate dressing, hydrocolloid dressing, etc., are essentially designed to manage the wound exudate and the moisture level in the wound bed. They do not have the biofunctionality to transform the microenvironment of the chronic wounds, proactively stimulate wound healing and accelerate the wound healing process. In our knowledge, there are still unfortunately few successful and widely adopted clinical therapies specific to diabetic ulcers beyond standard‐of‐care wound management, despite the vast number of scientific discoveries in the pathogenesis of impaired healing in patients living with diabetes [5].

Advanced wound matrices are a promising advanced therapeutic modality for chronic wounds. They are mainly designed to function as a scaffold for cellular ingrowth and angiogenesis, thereby promoting tissue healing and regeneration, along with their physical form factor as a covering for wound protection and exudate management [1, 6, 7, 8, 9]. Many advanced wound management products termed as Cellular/Tissue‐based Products (CTPs) or Cellular, Acellular and Matrix Products (CAMPs) have been developed and marketed to accelerate chronic wound healing. Analysis has shown that the earlier use of CTPs/CAMPs can heal the wound faster and decrease the risk of infection and the overall costs [10]. Based on materials, there are mainly two types of wound matrices, namely biologic and synthetic wound matrix. In comparison, the biologic wound matrix has the potential to elicit immune and/or inflammatory responses, while the synthetic wound matrix, composed of non‐biologic derived materials, provides multiple benefits for chronic wound healing without the drawbacks of the biologic products. Recently, a bioresorbable wound matrix product (Restrata, Acera Surgical, St. Louis, MO) demonstrated that it can accelerate chronic wound healing in a prospective multi‐centre clinical study. The product is made of degradable polymeric nanofibers manufactured from poly (lactic‐co‐glycolic acid) (PLGA) and polydioxanone (PDO). At the end of the 12‐week treatment period, 18 of 24 wounds (75%) reported complete wound closure, with the average time to complete wound closure 6.4 ± 2.5 weeks. The average reduction in wound surface area over 12 weeks was 96% ± 10% [11]. While these healing rates are significantly better than those observed in the current standard of care, this product still faces some challenges in fully meeting the clinical needs, for example, its rigid nature makes it difficult to apply to and integrate with the wound bed, and it takes longer than a week on average to degrade and incorporate into the wound—these limitations may hinder the wound healing process.

Leveraging the approach of first principal design, a novel wound matrix composed of electrospun composite nanofibers fabricated from PLGA and PDO was developed (Redermo, manufactured by the sponsor company). Both PLGA and PDO are well‐established bioresorbable synthetic polymers with extensive clinical precedent in medical devices, including absorbable sutures (e.g., Vicryl and PDS, respectively), surgical meshes and other implantable devices approved by regulatory authorities worldwide. As compared with other synthetic wound matrices, the product is designed to be softer, more hydrophilic and easier to integrate with wound bed. Also, the novel product utilizes different materials, proprietary ways of assembling different materials to make composite fibres (single fibre contains multiple different materials) and different special processing conditions to enable the product features for better clinical usability. The novelty of the subject wound matrix resides not in its base materials, which have an established clinical safety record, but in the proprietary composite nanofiber architecture and processing conditions that enable enhanced softness, hydrophilicity and conformability to irregular wound beds relative to existing synthetic wound matrices.

Made from PLGA and PDO—polymers with decades of documented clinical safety—this product possesses a three‐dimensional architecture of high porosity, with the hybrid nanoscale fibre diameter and pore size mimicking the native extracellular matrix and thereby supporting cellular adhesion, infiltration and neovascularisation in the wound healing process. When placed in the wound, it has a designed dynamic rate of degradation that makes space between the fibres over time, at a pace that matches the rate of wound healing with new tissue formation in the wound bed and re‐epithelialisation for wound closure. Moreover, the degradation of the synthetic materials in the product generates lactate‐rich, acidic degradants, which can proactively lower the pH in the wound to disrupt wound chronicity and provide lactate, the key factors that have shown pro‐healing capabilities from literature [12].

A pre‐clinical study evaluating the use of this novel synthetic nanofiber wound matrix in a clinically relevant porcine wound model has found that the wounds treated with the wound matrix had an equivalent wound healing response to the commercially available synthetic matrices and exhibited no adverse effect [13].

The objective of this study is to evaluate the clinical performance of the novel synthetic nanofiber wound matrix for the treatment of a chronic wounds cohort in a 1400‐bed medical centre in Eastern China.

2. Methods and Materials

2.1. Trial Design

This prospective, single‐centre, single‐arm pilot study was designed to provide initial clinical evidence on the performance of the subject wound matrix in the treatment of various chronic wounds, including DFUs, VLUs and PUs. The study was approved by the Institutional Review Board (IRB) in December 2023, and the patients were enrolled after the IRB approval. The study concept was initiated by the sponsor company. All clinical procedures, including patient enrolment, data collection, wound assessments and treatment decisions, were independently conducted by the treating physicians at the study site. Specifically, all procedures performed in this study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki. Written informed consent was obtained from all participants (or their legal guardians, if applicable) prior to enrolment in the study. The informed consent documentation included a description of the device composition (PLGA/PDO‐based nanofiber matrix), its intended mechanism of action, the bioresorbable nature of the materials and the regulatory status of the device. Participants were given the opportunity to ask questions prior to providing consent. The patients were required to have had non‐healing chronic wounds for at least four (4) weeks prior to enrolment and meet all the inclusion and exclusion criteria. The patients were enrolled sequentially, and all received the subject wound matrix for treatment. The patient and wound data were collected and documented prospectively by the treating physicians. Although no concurrent control group was included, the study design incorporated an inherent self‐control mechanism. All enrolled patients were required to have documented non‐healing wounds despite at least four (4) weeks of standard‐of‐care treatment prior to enrolment, establishing each wound's own trajectory of chronicity and treatment refractoriness. This pre‐enrolment period served as a de facto lead‐in period, against which subsequent wound area reduction (WAR) following application of the subject wound matrix was measured. Additionally, the clinical outcomes were benchmarked against published data from prospective studies evaluating standard‐of‐care controls for comparable wound populations, as detailed in the Discussion. Consent for use of the de‐identified data for medical research or education was provided by all patients (Ethical Approval No. 2023‐044‐01).

Prior to the initial treatment with the subject wound matrix, all wounds had been appropriately debrided per clinical protocol. The subject wound matrix was prepared for use, per the product instructions for use, including cutting to the appropriate size to match the size of the wound, applied to the wound bed and secured by a non‐adherent secondary dressing. Sterile gauze was used as the non‐adherent dressing, and no other functional dressings were applied. The subject wound matrix was re‐applied every seven (7) days or per the physician's discretion until the completion of the study after the 4‐week treatment and assessment period, per the study protocol.

Weekly follow‐up visits were performed. During these visits, patients may have received additional applications of the wound matrix for up to 4 weeks, when deemed appropriate by the physician. Then, the wound area was measured, and the wound condition, including the wound healing quality, was assessed and documented.

The wound area was measured by a digital App‐based measuring tool (Fariver Medical Technologies Co. Ltd.). Briefly, the imaging measurement was performed as follows: The wound was first placed in a single‐colour background. A standard area card was put 1–2 cm in the periphery of the wound as a reference to support software recognition and benchmarking. Place the photographic equipment directly above the wound to take a photo of the wound while making sure the wound falls in the centre of the viewfinder frame provided by the equipment. The App is a skin/wound analysis system, enabled by an artificial intelligence image processing methodology to automatically perform accurate quantitative analysis of skin wounds, with integrated, built‐in image acquisition, quantitative analysis, storage and retrieval functions [14].

2.2. Participants

Subjects were required to meet all inclusion and exclusion criteria to participate in the study. Inclusion and exclusion criteria utilized to screen study participants are listed in Table 1.

TABLE 1.

Inclusion and exclusion criteria for patient enrolment.

Inclusion criteria

Exclusion criteria

Patients aged 18–75 years (inclusive), regardless of gender; Individuals that need the management of chronic wounds, such as diabetic ulcers, venous ulcers and pressure sores/ulcers; Wound area less than 35 cm2, regardless of specific location, but with no bone involvement or bone exposure; Wound without excessive exudate; Voluntarily participating in the pilot study and signing the informed consent form.

Patients with severe uncontrolled diseases or advanced illnesses, combined with serious organ diseases of the heart, lungs, brain and so on; Existing diseases that would affect wound healing, such as severe anaemia (Hb < 60 g/L), hypoalbuminemia (ALB < 25 g/L), malignant tumours, autoimmune connective tissue diseases and so on; Radiation ulcers and ulcers with malignant lesions; Currently receiving radiotherapy, chemotherapy, or taking hormones or immunosuppressants; Severe immune system diseases, diabetic patients unable to control blood glucose ≤ 10 mmol/L and maintain this level for 3 days or more; Pregnant or lactating women; Individuals with history of allergy to the product components; Patients with poor compliance, life‐threatening conditions, or inability to complete the treatment course; Patients with severely infected wounds, extensive necrotic tissue in the wound, or wound sepsis; Patients with wounds within 3 cm of the target treatment wound; Patients who are mentally incapable or unable to understand the requirements of participation in the study; Individuals deemed unsuitable for participation in this pilot study by the researchers.

2.3. Endpoints

The primary endpoint measure was the WAR percentage rate at Week 4. Secondary endpoints included the wound infection rate, product condition in the wound during use, healing time and quantity of product usage. Safety endpoints included the incidence of adverse events (AEs), serious adverse events (SAEs), device‐related AEs, wound infection rate, device defects or malfunctions and vital sign monitoring (body temperature, pulse rate and blood pressure) at each weekly follow‐up visit.

3. Results

The study was conducted between Jan 2024 and May 2024. All subjects received the planned intervention. Data from 15 patients with 15 wounds treated with the subject wound matrix were included in the reported results shown in Table 2. Specifically, the participants included 8 women (53.3%), and the average age of all patients was 62.73 ± 8.03 years, with the range between 41 and 73 years. The wound types included five (5) DFUs (33.3%), eight (8) VLUs (53.3%) and two (2) PUs (13.3%). The all DFUs enrolled were in Wagner Grade 1 or 2. The average wound size at baseline was 7.2 ± 5.9 cm² for all wound types. The average size of DFUs was 7.7 ± 7.5 cm², the average size of VLUs was 7.5 ± 6.0 cm² and the average size of PUs was 4.9 ± 1.8 cm².

TABLE 2.

Subject demographics and baseline wound characteristics.

		All wounds (n = 15)	DFUs (n = 5)	VLUs (n = 8)	PUs (n = 2)
Gender, n (%)	Male	7 (46.7%)	—	—	—
	Female	8 (53.3%)	—	—	—
Age, years	Mean ± SD	62.73 ± 8.03	63.40 ± 4.61	60.50 ± 9.29	50.50 ± 3.53
Weight, kg	Mean ± SD	62.53 ± 16.27	—	—	—
Temperature, °C	Mean ± SD	36.27 ± 0.12	—	—	—
Pulse rate n/min	Mean ± SD	78.93 ± 3.66	—	—	—
Systolic blood pressure, mmHg	Mean ± SD	131.47 ± 21.44	—	—	—
Diastolic blood pressure, mmHg	Mean ± SD	81.87 ± 12.61	—	—	—
Wound area, cm2	Mean ± SD	7.2 ± 5.9	7.7 ± 7.5	7.5 ± 6.0	4.9 ± 1.8

3.1. Safety

No AEs, SAEs, or device‐related complications were reported in any of the 15 patients during the entire 4‐week treatment period. Specifically, no wound infections, no allergic or hypersensitivity reactions, no excessive inflammatory responses attributable to the wound matrix and no device defects or malfunctions were observed. All patients' vital signs, including body temperature (36.27°C ± 0.12°C), pulse rate (78.93 ± 3.66/min), systolic blood pressure (131.47 ± 21.44 mmHg) and diastolic blood pressure (81.87 ± 12.61 mmHg), remained within normal ranges at all weekly follow‐up visits (Table 2). No patients discontinued the study due to safety concerns.

Overall observations indicated that the chronic wounds treated with the subject wound matrix have shown significant improvement in wound healing, illustrated in Figure 1.

FIGURE 1.

Representative images of wound healing after treatment.

The wounds demonstrated progressive and sustained WAR over the entire period of treatment (Table 3). Overall, 7 of the 15 wounds (46.7%) achieved 100% WAR at Week 3. Specifically, two of the five DFU wounds (40%) achieved 100% WAR at Week 1; four of the eight VLU wounds (50%) achieved 100% WAR at Week 3; and one of the two PU wounds (50%) achieved 100% WAR at Week 3. The WAR for all wounds was 83.6% ± 19.7% at Week 4. Particularly, the WAR for DFUs and VLUs at Week 4 was 75.6% ± 26.9% and 87.5% ± 15.4%, respectively and the WAR for PUs at Week 3 was 93.1% ± 9.7%.

TABLE 3.

Wound area reduction (WAR) percentage rates at different time points.

Mean ± SD	All wounds (n = 15)	DFUs (n = 5)	VLUs (n = 8)	PUs (n = 2)
WAR Week 1 (%)	43.5 ± 40.7	44.4 ± 51.2	30.5 ± 63.7	—
WAR Week 2 (%)	62.8 ± 35.1	61.9 ± 35.4	61.7 ± 39.3	—
WAR Week 3 (%)	79.3 ± 24.2	66.0 ± 31.6	84.2 ± 19.6	93.15 ± 9.69
WAR Week 4 (%)	83.6 ± 19.7	75.6 ± 26.9	87.5 ± 15.4	—

Note: 1. One of the two PU wounds did not provide the wound area at Week 1, as the dressing change was performed at home. One of the two PU wounds did not provide the wound area at Week 2, as the dressing change was performed at home. 2. One of the two PU wounds (50%) achieved 100% wound area reduction at Week 3, while the other case demonstrated 86.3% wound area reduction at Week 3. Because the wound is almost healed, the patient insisted on leaving the clinical study. The PU subgroup results (n = 2) should be interpreted with particular caution given the very small sample size and are presented for descriptive purposes only. 3. The mathematical formula for wound area reduction percentage rate calculation: $\mathrm{WAR}=\left[\left(\text{Wound Area}1-\text{Wound Area}2\right)/\text{Wound Area}1\right]\times 100\%$. Wound Area1: wound area at enrolment and/or before treatment, Wound Area2: wound area after treatment.

During the 4‐week treatment period, a total of seven wounds achieved complete healing (100% WAR rate), accounting for 46.67% of all trial cases (n = 15). For these seven completely healed wounds, the average healing time was 13.86 ± 6.15 days (Mean ± SD). Specifically, the average wound healing time for DFUs, VLUs and PUs was 6 ± 0, 16 ± 3.37 and 21 ± 0 days (Mean ± SD), respectively.

The product degradation morphology was also reported during the 4‐week treatment period. The subject wound matrix is completely absorbable, and a single application, that is, single layer of the product, can degrade in the wound in approximately one (1) week. In our observation, the degradation is positively correlated with the wound exudate level, and 2.93 ± 1.28 pieces per patient on average were used during the 4‐week treatment in the study (Table 4).

TABLE 4.

Degradation morphology rating.

Rating	Degradation morphology	Number of observation, n (%)
0	Product is dry, no liquid absorption. Morphology intact.	0 (0.0%)
1	Product has absorbed exudate, moist, but morphology intact.	2 (13.3%)
2	Product has absorbed exudate, moist, partially fragmented, showing signs of degradation (< 1/4).	8 (53.3%)
3	Product largely degraded (1/4–3/4) and incorporated with the wound.	2 (13.3%)
4	Product has completely degraded, basically unobservable, fully incorporated into the wound.	3 (20.0%)

Note: The degradation morphology rating scale was developed by the sponsor company as a descriptive observational tool for product degradation assessment; it was not used to guide clinical treatment decisions or endpoint evaluation.

4. Discussion

The results of this prospective, single‐arm pilot study demonstrate that the subject wound matrix, a novel synthetic absorbable nanofiber wound matrix, can significantly accelerate healing of chronic wounds, including DFUs, VLUs and PUs. The overall WAR rate of 83.6% after only four (4) weeks of treatment and the 46.7% complete wound closure rate by Week 3 represent clinically meaningful advancement, as compared to the standard of care and previous studies on other synthetic wound matrix products [11, 15, 16]. These findings contribute important clinical insights into emerging strategies for the management of chronic wounds, a patient population notoriously resistant to healing and associated with substantial morbidity.

The accelerated healing observed with the subject wound matrix is likely attributable to several key factors inherent to its design and mechanism of action. Unlike biologic wound matrices, which can provoke immune or inflammatory reactions, the fully synthetic composition of the subject wound matrix provides enhanced biocompatibility and reduced immune response risks. The micro‐architecture of the subject wound matrix mimics the native extracellular matrix, which is designed to support cellular adhesion, infiltration and neovascularisation, the essential physiologic processes for tissue regeneration and wound repair. It is well known that blood‐borne immunocompetent cells and bone marrow‐derived stem cells will invade the wound area during the inflammatory phase of wound healing [17, 18]. It is proved that these mesenchymal stem cells (MSCs) can promote healing of non‐healing chronic wounds [19]. Furthermore, the dynamic degradation profile of the product aligns with the pace of tissue formation in chronic wounds, creating a dynamic scaffold that precisely adapts to the evolving needs of the wound over the sequential healing cascades and promoting effective and efficient granulation in the wound bed and re‐epithelialisation. Notably, the by‐products from the degradation process, especially lactic acid, help modulate the wound micro‐environment by lowering the pH in the wound, which disrupts the chronic inflammation and enhances tissue regeneration [20, 21, 22, 23, 24].

The encouraging clinical outcomes observed with the subject wound matrix are particularly notable when directly compared to data from a previous prospective, blinded, randomized controlled clinical trial evaluating a similar synthetic wound matrix (Restrata, Acera Surgical Inc. St. Louis, MO) [25]. In the study, DFUs treated with the device demonstrated a mean WAR of 64.9% in the intent‐to‐treat (ITT) population over a 12‐week treatment period. The per‐protocol (PP) population, which represented patients meeting all eligibility criteria and receiving full treatment as planned, showed an even higher mean WAR of 89.3% at 12 weeks. The average wound size in the ITT group for the device was relatively small, at 3.9 ± 5.1 cm².

In comparison, our study assessing the subject wound matrix reported a mean WAR of 75.6% in DFUs after only 4 weeks of treatment, with a larger average baseline wound size of 7.7 ± 7.5 cm². This suggests that the subject wound matrix in our study may promote more rapid wound healing, even in larger wounds, relative to the literature device's longer treatment timeframe. The accelerated healing with the subject wound matrix is further supported by the high proportion of wounds achieving complete closure—46.7% of wounds treated with the subject wound matrix completely healed within 3 weeks, contrasted against the standard of care in the literature trial, where only 33.3% of wounds were fully healed by 12 weeks. These findings indicate that the subject wound matrix may offer a clinically significant advantage in healing velocity and efficacy over both standard of care and prior synthetic wound matrices.

From a health economics perspective, chronic wounds, particularly DFUs, are well recognized as a heavy burden on healthcare systems globally due to prolonged treatment courses, high rates of complications including infections and amputations and recurrent care needs [26]. Cost analyses indicate that traditional standard of care for DFUs is often associated with exorbitant expenses, running into tens of thousands of dollars per patient annually, with considerable indirect costs related to productivity loss and quality of life impairment. With emerging advanced therapies such as CTPs or CAMPs, cost‐effectiveness is a critical consideration, as these treatments generally have higher upfront costs but may lead to substantial long‐term savings through faster healing, reduced complications and fewer hospitalisations.

Recent economic evaluations of commonly used skin substitutes consistently show that incorporation of advanced wound matrices into standard treatment regimens can be cost‐effective or cost‐saving compared to standard of care alone. For instance, cellular and acellular therapies such as cryopreserved placental membranes and bioengineered cellular constructs have demonstrated improvements in healing rates that translate to fewer wound care visits and reduced resource utilisation, with economic models projecting millions of dollars in savings per year for healthcare providers managing chronic wounds [27]. Although cost‐effectiveness analyses specifically involving synthetic nanofiber matrices like the subject wound matrix are currently limited, the accelerated healing observed here suggests potential for improved economic outcomes. Reduced time to wound closure implies fewer product applications, shorter treatment durations and decreased risk of costly complications such as infection and amputation, all of which are vital to lowering overall treatment expenditure.

Moreover, the approximately 7–14 days absorption profile of the subject wound matrix in the wound and its reapplication regimen may offer practical advantages by minimizing wound dressing change frequency, lowering nursing time and enhancing patient compliance. This not only benefits healthcare providers by reducing operational costs but also enhances patient quality of life by decreasing discomfort and interruption to daily activities. Previous studies of synthetic hybrid‐scale fibre matrices have also reported favourable clinical versatility and economic benefits across a range of wound types, underscoring the potential broad applicability of this therapeutic modality within limb salvage and wound care practices [28].

5. Limitation

Despite the encouraging outcomes, some limitations should be acknowledged. The small sample size and single‐centre design necessitate caution in generalizing these findings broadly. Furthermore, the absence of a concurrent control group limits the ability to draw definitive causal inferences; the observed improvements cannot be solely attributed to the subject wound matrix independent of other factors such as regression to the mean, natural wound healing trajectory, or the Hawthorne effect. The heterogeneity of wound types (DFUs, VLUs and PUs), while reflecting real‐world clinical practice, limits wound‐type‐specific conclusions due to small subgroup sizes (n = 5 for DFUs, n = 8 for VLUs, n = 2 for PUs). Future larger, multicentre randomized controlled trials with wound‐type stratification, concurrent standard‐of‐care control arms and diverse patient populations are warranted to provide higher‐level evidence, validate clinical efficacy, optimize treatment protocols and further explore health economic impacts. Additionally, while short‐term healing rates are promising, longer‐term follow‐up is needed to assess durability of wound closure, recurrence rates and any potential device‐related adverse effects. Future studies incorporating comprehensive cost‐utility analyses could provide more definitive evidence of the value proposition of the subject wound matrix in complex wound care.

6. Conclusions

In a prospective, single‐centre, single‐arm pilot study, the subject wound matrix, a novel nanofiber wound matrix, demonstrated accelerated healing in various chronic wounds including DFUs, VLUs and PUs, as compared to standard‐of‐care treatment options. We observed that 46.7% of wounds treated with the subject wound matrix completely healed at Week 3 and the WAR rate for all wounds was 83.6% at Week 4. The results indicate that the subject wound matrix can provide significant clinical and economic benefits for chronic wounds compared with standard of care today.

Funding

This study was funded by Kreate Medical Inc., which also provided the subject wound matrix (Redermo) for clinical use. The study concept was initiated by Kreate Medical. All clinical procedures, including patient enrolment, data collection, wound assessments and treatment decisions, were independently conducted by the treating physicians at The People's Hospital of Chizhou. Kreate Medical Inc. had no role in patient enrolment, clinical data collection, wound assessment, data analysis, or interpretation of clinical results.

Ethics Statement

This study was reviewed and approved by the Ethics Committee of The People's Hospital of Chizhou (Approval No.: 2023‐044‐01). All procedures performed in this study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki. Written informed consent was obtained from all participants (or their legal guardians, if applicable) prior to enrolment in the study.

Conflicts of Interest

Sean Chen is the founder and an employee of Kreate Medical, the manufacturer of the subject wound matrix (Redermo) evaluated in this study. He participated in study conceptualisation, project administration and manuscript review, representing a potential source of bias. Lifang Qian, Jingyun Fang and Yong He are physicians at The People's Hospital of Chizhou and declare no financial relationships with Kreate Medical. Meiqin Ni and Yiyu Sun declare no conflicts of interest. To mitigate potential bias, all clinical data collection, wound assessments and treatment decisions were performed independently by the treating physicians at the clinical centre.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.