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NCT05193929
The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.
NCT07463456
This cross-sectional observational study validates the concordance of a low-cost thermographic camera (HIKMICRO Mini2 V2, \~200 Euro) against a professional clinical standard (HIKMICRO M60) for diabetic foot assessment. Both cameras simultaneously capture plantar thermographic images from 130 participants with diabetes mellitus. Maximum contralateral thermal asymmetry (Delta T\_max) across 6 plantar regions of interest (ROIs) is the primary endpoint, analyzed by intraclass correlation coefficient (ICC) and Bland-Altman method.
NCT07465640
Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour/day, 2 hours/day, and 3 hours/day for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H\&E) staining, and immunohistology (for vascular endothelial growth factor \[VEGF\] and fibroblast growth factor 2 \[FGF-2\] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.
NCT07039396
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
NCT05977309
Despite conflicting and contradictory evidence regarding its efficacy, some wound care centres have advocated and adopted ozone for treating DFU. However, there are gaps in the application of topical ozone therapy. Reported no significant impact on the healing process of DFU, and not all said that topical ozone can enhance the healing process. This study aimed to compare the efficacy of topical ozone therapy in conjunction with standard wound care versus routine wound care alone in treating DFU. The wound, ischemia, and foot infection (WIFI) scale was used to measure wound size, the tissue survival rate at DFU, infection, peripheral microcirculation, glycemic control, Hba1c control, and wound healing.
NCT06111183
This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.
NCT07396376
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the treatment of chronic diabetic foot ulcers (DFU). ELU42 combines a tankyrase inhibitor (XAV939) with a novel derivatized hyaluronic acid excipient (DHA77) and is applied as a topical spray to the index ulcer. Fifteen adults with Wagner grade 1-2 diabetic foot ulcers that have been present for at least 4 weeks and up to 52 weeks will be enrolled across up to four U.S. clinical sites. After a 2 week run in period during which standard of care (SOC) is provided (off loading, dressings, and debridement), subjects will receive ELU42 applied on site by trained study staff or the investigator three times per week (Monday, Wednesday, Friday) for six weeks (up to 18 applications). Subjects will be followed weekly during treatment and for up to 6 weeks after the final dose; additional Healing Confirmation visits are scheduled if the wound closes to evaluate the subjects over a course of a 3 month period. The study's co-primary objectives are to assess safety (incidence and severity of adverse events and infections) and to measure percent area reduction (PAR) of the index ulcer at Weeks 4 and 6. Efficacy assessments will be performed by the site investigator using direct two axis planimetry and by automated evaluation using the Tissue Analytics platform (surface area, volume, and PAR). Secondary and exploratory assessments include patient reported outcomes (Wound Q and SF 36), frequency of complete wound healing, wound hydration metrics, and pharmacokinetic sampling in a subset of subjects. Contact information for potential participants and referring clinicians is available at each participating site.
NCT07368816
This study is a prospective randomized controlled pilot study evaluating the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Participants were randomly assigned at enrollment to receive either the OEOd-based dressing or standard therapy. The primary outcome was complete ulcer healing at 16 weeks. Secondary outcomes included new infections, need for additional surgical debridement, re-hospitalization, and time to healing. The study was designed to provide preliminary estimates of treatment effect and feasibility to inform future larger randomized trials.
NCT05595681
The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C\_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.
NCT05948592
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).
NCT07277010
Diabetes is one of the major chronic diseases, and diabetic foot ulcer (DFU) is a significant adverse prognosis of diabetes. The recurrence of DFU after healing involves multiple risk factors, such as changes in foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, the degree of ischemia, and control of systemic diseases. Early identification of signs of DFU recurrence and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies (e.g., insufficient risk stratification, rigid follow-up intervals, inadequate compliance management), often resulting in low follow-up efficacy. High-risk patients prone to recurrence may not receive frequent enough follow-ups for early detection, while low-risk patients unlikely to recur may undergo multiple unnecessary visits, increasing the burden on both patients and healthcare providers. This inefficiency is a key reason for the persistently high rates of disability and mortality among patients with recurrent DFU. Establishing individualized follow-up strategies for DFU, leveraging advanced technologies to address core bottlenecks such as delayed recurrence warnings and insufficient home management, represents an effective technical approach to solving these problems. Our center aims to establish and refine a specialized cohort for active DFU follow-up, along with a multimodal database with comprehensive indicators. We plan to explore a high-risk foot grading system for preventing DFU recurrence and develop targeted follow-up protocols. Using AI technology, we will create a wound alert system capable of identifying DFU recurrence and explore a remote healthcare and AI-assisted prevention and control system for DFU recurrence, centered on patient self-management at home.
NCT07116876
This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.
NCT07271550
This study aims to evaluate a new Arabic version of the NAFF questionnaire, which measures foot care behaviors in adults with type 2 diabetes. Participants are adults with type 2 diabetes who will complete the questionnaire online. The study will assess how reliable and valid the Arabic version is, helping healthcare providers identify risky foot care behaviors and improve patient education.
NCT07270328
This pilot feasibility and exploratory study, conducted to prepare for a definitive Randomized Controlled Trial (RCT), compares a structured foot-ankle exercise program with a walking exercise program in adults with Diabetes Mellitus (DM). The primary aim is to assess feasibility, including recruitment rate, retention, adherence, data completeness, acceptability, and adverse events, to inform procedures for the definitive RCT. The secondary (exploratory) aim is to obtain preliminary estimates of effects on Diabetic Peripheral Neuropathy (DPN), stress, and obstacles to Diabetes-Related Quality of Life (DR-QoL), Fasting Blood Glucose (FBG), Body Mass Index (BMI), blood pressure, and Ankle-Brachial Index (ABI). Participants were allocated to three parallel arms for 12 weeks: 1. Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day), 2. Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or 3. Active control (education and printed materials). Outcomes were assessed at baseline (day 0), week 6, and week 12. Analyses focus on feasibility metrics against pre-specified progression criteria and on hypothesis-generating estimates of within- and between-group change in neuropathy, stress, and obstacles to DR-QoL; the study is not powered for definitive efficacy. Retrospective registration note: This study was registered retrospectively after participant enrolment had begun and data collection had been completed. This retrospective status is disclosed for transparency; exploratory outcome analyses are interpreted accordingly, and adverse events related to exercise were monitored and reported.
NCT07262203
This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and amputation. Early identification and non-pharmacological interventions such as structured lower extremity exercises may help improve peripheral circulation. In this study, 44 adults with type 2 diabetes mellitus who met the inclusion criteria were randomly assigned to either an intervention group receiving diabetic foot exercises or a control group performing regular physical activity of similar frequency and duration. The exercise protocol used in the intervention group was adapted from the Joslin Diabetes Center and included balance, strengthening, and ankle-foot mobility exercises. The intervention lasted for 3 months. Peripheral vascular status was assessed using the ankle-brachial index (ABI) measured with a Doppler device at baseline and after 3 months. The study found that participants in the intervention group demonstrated a significant improvement in ABI values compared with the control group, indicating enhanced lower-limb blood flow. This trial provides evidence that diabetic foot exercises are a simple, low-cost, and feasible intervention to improve peripheral vascular circulation in patients with type 2 diabetes mellitus, particularly in settings with limited resources.
NCT07046403
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.
NCT07198061
The goal of this clinical trial is to evaluate whether cold atmospheric plasma (CAP) combined with endovascular intervention can accelerate wound healing and improve safety outcomes in patients aged 18 to 80 years with diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion. The main questions it aims to answer are: 1. Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?; 2. Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?; Researchers will compare CAP treatment plus standard care to sham CAP (placebo) plus standard care to see if CAP improves wound healing more effectively and reduces adverse local symptoms. Participants will: 1. Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation 2. Undergo daily wound assessments for ulcer area, signs of infection, and pain scores 3. Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4 4. Be followed through Week 4 to assess efficacy and safety endpoints
NCT07014176
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
NCT07099482
This study aims to evaluate whether using ultrasound (phonophoresis) can help deliver propolis-a natural compound made by bees-more effectively into the skin to speed up wound healing in people with diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and often take a long time to heal. Propolis has natural anti-inflammatory and antimicrobial properties that may promote healing, but it does not easily penetrate the skin. By using ultrasound to enhance absorption, this study tests whether combining propolis with phonophoresis is more effective than standard wound care alone. Participants will be randomly assigned to receive either the propolis ultrasound therapy or standard care. The study will measure wound size, healing time, pain, infection rates, and quality of life.
NCT07193992
Diabetes mellitus is a chronic disease that occurs either when pancreas does not produce enough insulin or when the body can't use it effectively. Diabetes mellitus include : type 1(insulin deficiency) , type 2 ( insulin resistance ) , gestational diabetes, maturity onset diabetes of the young ( MODY) , neonatal DM , wolfram syndrome, latent autoimmune diabetes in adults ( LADA ) , type 3 c diabetes, steroids - induced diabetes, cystic fibrosis disease ,Type 5 diabetes( Malnutrition related diabetes) which affect between 20-25 million primarily in Asia \& Africa. According to WHO the number of living people with diabetes rose from 200 million in 1990 to 830 million in 2022 . According to IDF : The latest atlas 2025 report that 11.1% or 1- 9 of adult population ( 20 - 79 ) is living with diabetes, which 4 in 10 unaware of their condition. One of the serious complications is Diabetic foot ulcers . The global prevalence of DFU is around 6.3 % while the annual incidence reported between9.1 to 26.1 million cases, that's mean that 1 in 16 of diabetic patients experiences a DFUs . DFUs can be defined as wound or ulceration on the foot of diabetic patients due to a combination of factors such as neuropathy, peripheral artery disease, trauma or pressure . DFUs can lead to serious complications up to death like infection, osteomyelitis, limb amputation that significantly impact a person's quality of life, causing pain, disability and psychological distress. Beyond that immediate impact on patients, but also affect their families, and the healthcare system so it's considered as an economic burden due to health care costs and lost productivity. So to solve the problem we should know what cause it first and so we can prevent it before happening, not just finding a solution and that will affect not just the patients and their families, but also the country. Non vascular risk factors significantly impact DFU severity and healing including neuropathy, infection, poor glycemic control, obesity , inadequate foot care, certain immunological and inflammatory responses , age , malnutrition, smoking, High BMI , repetitive stress and pressure, certain foot conditions like onychomycosis and even iron deficiency anemia have been linked to it .