Clinical Research Directory

DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman

This study aims to evaluate DiaFootCare, a mobile health application designed to support self-care and monitoring among adults with diabetic foot ulcers. The application provides educational and self-care support, medication and care reminders, wound monitoring using standardized foot photographs, and communication of relevant information to support pharmacist-led monitoring. The study will evaluate the usability and effectiveness of DiaFootCare among patients with diabetic foot ulcers receiving care at the National Diabetes and Endocrine Centre in Oman. Participants using DiaFootCare will be compared with participants receiving usual care. The study will assess outcomes related to diabetic foot self-care, medication adherence, glycemic control, wound healing, and participants' use of and engagement with the application.

A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL

The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.

Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing

Diabetic symmetrical polyneuropathy (DSPN) is a common complication of diabetes that affects the nerves, especially in the legs and feet. It can cause pain, numbness, tingling, weakness, and loss of sensation. These problems can affect daily activities and quality of life. Loss of sensation can also increase the risk of foot wounds and problems with wound healing. This study is comparing two treatments in people with type 2 diabetes and DSPN. The main purpose is to find out whether a combination of alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E is providing greater improvement in neuropathy symptoms than vitamins B1, B6, and B12 alone. The study is also examining changes in wound healing. About 100 participants are taking part at Hospital Canselor Tuanku Muhriz (HCTM). Participants are being randomly assigned to one of two treatment groups. One group is receiving Bionerv E+, which contains alpha-lipoic acid, vitamins B1, B6, B12, and vitamin E. The other group is receiving a vitamin B-complex containing vitamins B1, B6, and B12. Both treatments are being taken daily for 12 weeks in addition to standard treatment for DSPN. Researchers are assessing participants before and after treatment. These assessments are examining nerve problems in the lower limbs, pain, quality of life, and blood markers related to inflammation. For participants with diabetic foot ulcers, researchers are also assessing changes in the wounds.

A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds

This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.

Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database. Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies. Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months. Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.

Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers

To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic Diabetic Foot Ulcers.

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

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.

HPTC Versus AFSM in Diabetic Foot Ulcers

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.

A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers

The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers. The main question it aims to answer is: How well does VES-0-D gel support wound healing, compared with a standard wound treatment? Other questions that are the target of the investigation are: * the evaluation of wound characteristics relevant to healing * the evaluation of side effects at the site of application The investigation will compare the wound area reduction over the 8 week treatment for VES-0-D vs standard of care treated patients. The investigation will also collect wound assessment scoring results over the entire study duration as well as safety data on VES-0-D. Participants will: Have VES-0-D or standard of care applied every 3-4 days for 8 weeks, either at home or in the clinic Visit the clinic once every week for checkups and assessments. Keep a diary of their applications and any symptoms they might experience

CARE-D-FOOT-Nav Pilot

This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav). Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise. Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed. This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.

Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue

The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy

Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care

This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.

The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care

The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU). The ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations (SIC) addressing patients' health situation, concerns, priorities, and preferences for care. Relatives may be involved when appropriate. The study examines the feasibility, acceptability, and appropriateness of the ProActive model and its implementation from the perspectives of patients, relatives, and healthcare professionals. It also evaluates the feasibility of outcome measures and data collection procedures for a future effectiveness study and examines the procedures used to identify patients who may benefit from the intervention. The feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.

The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.

Primary outcome: To evaluate the efficacy of L-Carnitine supplementation on length and depth ulcer size Secondary outcome: To investigate the effect of L-Carnitine supplements on: 1. Vascular endothelial growth factor (VEGF) 2. Inflammatory markers TNF-a (Tumor necrosis factor alpha). 3. Hemoglobin A1C (HbA1c) And Lipid profile (cholesterol, triglycerides, high-density Lipoprotein (HDL) and low-density lipoprotein (LDL)). 4. To assess the type and likelihood of any adverse drug reaction that can be related to L-Carnitine supplementation. 5. QOL (DIABETES 39)

Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers

The TSS project is a study of the effects of treating hard-to-heal ulcers in a multidisciplinary cross sectional team, meaning that nurse and doctor from a hospital based wound healing clinic and wound care nurse from the primary care sector treat the patient in collaboration rather than the current form where care in municipalities and hospital setting, communicate but treat the patient on their own. The study is designed as a randomized study, meaning that individuals with hard-to-heal ulcers are randomly designated to standard care or the multidis-ciplinary team. We measure several aspects of the new format, but the main outcome com-pared between the two groups (standard care and multidisciplinary care) is number of ulcers healed. Participants are followed for a year after inclusion in the study, and have 6 fixed visits in the clinic, with the possibility of more visits if necessary. There is no "new" medicine, surgery or other treatments planned in the study, but the multi-disciplinary team can offer and implement any treatment deemed appropriate for the individ-ual that is allocated to the multidisciplinary team, of course the individual has the opportunity to decline any treatment offered by the team. The control group, i.e. individuals allocated to standard care, will receive the treatment that is normally available to individuals with hard-to-heal ulcers treated in the municipality, including referral to hospital based treatments.

CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs

CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters

Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance, physiological expenditure index and gait parameters in diabetic individuals. Within the scope of this project, based on the above mentioned reasons, we plan to produce a personalised off loading insoles designed for diabetic foot.

Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application

This prospective interventional clinical study aims to evaluate the safety and therapeutic efficacy of air-dried human amniotic membrane (hAM) sterilized using different doses of gamma irradiation for regenerative medical applications. Gamma irradiation is employed as a terminal sterilization method to ensure microbiological safety while preserving the structural integrity and biological properties of the membrane. Within the same clinical protocol, the gamma-sterilized hAM will be applied to two distinct patient cohorts: individuals with diabetic foot ulcers (DFU) and patients with corneal ulcers. In the DFU cohort, the membrane will be used as a biological dressing to promote wound closure, enhance granulation tissue formation, reduce infection risk, and accelerate epithelialization. In the corneal ulcer cohort, the membrane will be applied to support corneal surface reconstruction, promote epithelial healing, reduce inflammation, and prevent complications. Participants in both cohorts will be monitored for clinical outcomes including rate of wound healing, time to complete epithelialization, infection rate, pain reduction, corneal re-epithelialization, and overall tissue regeneration quality. Clinical outcomes will be compared among membranes sterilized at different gamma irradiation doses to determine the optimal dose that ensures effective sterilization while maintaining biological activity and therapeutic performance.

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

Risk Perception Intervention for High-Risk Diabetic Foot

This study aims to evaluate the effect of health education based on information framing effects on foot ulcer risk perception in patients at high risk of diabetic foot. Study Design: A randomized controlled trial with three groups: Experimental Group 1 (Gain-Framed): Participants received a benefit framing message that emphasized the benefits of standardized foot care in reducing the likelihood and severity of foot ulcers, with an aim to reshape patients' perception of risk. Experimental Group 2 (Loss-Framed):Participants received a loss frame message that emphasized that neglecting foot care would increase the likelihood and severity of foot ulcers. The message was designed to awaken patients' awareness of crisis and risk perception. Control Group (Routine Messaging):Participants received the usual content of care in the endocrinology department without a specific framework. Participants: Diabetic foot patients at high risk from experimental group 1, experimental group 2, and control group 3. Inclusion criteria included adults with a diagnosis of diabetic foot at high risk. Intervention: The Total Study Period consisted of an intervention phase and a follow-up phase. The intervention phase started at the time of enrollment and lasted until the fourth week after discharge. The follow-up period lasted for 3 months. Data on local indicators were collected at baseline/before the intervention (T0), immediately after the intervention (T1), 1 month after the intervention (T2) and 3 months after the intervention (T3). Outcome Measures: Primary Outcomes: Foot ulcer risk perception: Assessed using The Tripartite Model of Risk Perception Scale. Secondary Outcomes: Foot care behavior score: Assessed using The Nottingham Foot Care Assessment Scale; Self-efficacy: Assessed using The Diabetes Self-Efficacy Scale; Intention to delay seeking medical help score:Assessed using the Questionnaire on Intention to Delay Seeking Medical Care for Patients with High-Risk Diabetic Foot; the incidence/recurrence rate of foot ulcers, and various laboratory indicators.

Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management

The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size over time. The study also looks at whether the dressings improve the condition of the wound and the surrounding skin. In addition, patients are asked about their experience with the dressings, including whether they help reduce pain and how satisfied patients are with the treatment.

PAW-Hydrogel for Chronic Wound Healing

The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are: * Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care? * Does PAW-hydrogel reduce bacterial load in the wound bed? * Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)? Participants will be randomly assigned to one of two groups: * Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week. * Control group: Standard advanced wound care (cleaning, debridement, conventional dressings). Wound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.

Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:

Protocol No. CHLORIN E6-IIB/III-01/Protocol/1.1 Title:Single-Centre, open-labeled, randomized, Phase IIb and Phase III clinical studies to evaluate the safety, tolerability, and efficacy of Chlorin E6 (Gel Formation) as a photosensitizing agent for the management of Diabetic Foot Ulcers with Photodynamic Therapy. Sponsor Synverdis GmbH, Heidelberg, Germany. Study Phase: Phase IIb(Completed) \& Phase III(Ongoing) Indication : Diabetic Foot Ulcers Study Population: This study will be conducted on diabetic participants who are 18 years of age or older, with a documented diagnosis of diabetes and foot ulceration that has been present for at least 4 weeks. Sample Size of Phase IIb: 30 participants were enrolled. Phase III: 300 participants will be enrolled. Intervention Investigational Product: Chlorin E6 gel Specification: 1.0 mg/cm2 of Chlorin E6 1% W/V in gel-form Formulation: Gel Storage and Transportation: Store and ship at 2\~8°C, avoiding freezing. Standard of Care Treatment: a. Surgical Intervention: Debridement of the wound will be performed for all the participants. b. Medical Intervention: i. Antibiotics: Targeted to aerobic Gram-positive cocci in mild to moderate infections. \- Moxifloxacin * Linezolid * Co-Amoxiclav * Piperacillin + Tazobactam * Clindamycin Dosage \& Application Patients will receive 1.0 mg/cm2 of Chlorin E6 1% W/V in gel form by local application on the ulcer. Approximately 30 minutes after the study drug administration, the ulcer will be washed thoroughly with normal saline. Then it will be illuminated with light at 660 to 670 nm from an approved laser source with a calculated light dose of 100 J/cm2. Light will be applied to the entire surface of the ulcer for 11 minutes. The wound will then be illuminated with UV light to assess the effectiveness of Photodynamic Therapy (PDT) and a further 11 minutes of therapy will be carried out if required. Study Objectives Phase IIb: Primary Objectives: 1. To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers. 2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by a reduction in size and depth of the ulcer. 3. To compare the efficacy and healing rates of Diabetic foot ulcers with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care (SOC) management. 4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy. Phase III: Primary Objectives: 1. To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers. 2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by reduction in size and depth of ulcer. 3. To compare the efficacy and rates of healing of Diabetic Foot Ulcer (DFU) with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care management. 4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy. Secondary Objectives: 1. To determine the rates of recurrence of diabetic foot ulcers during 6 months after local Chlorin E6-mediated Photodynamic Therapy. 2. To determine the reduction in rates of amputation during 6 months after local Chlorin E6-mediated Photodynamic Therapy. Study Endpoints Phase IIb: Primary endpoints: Safety: • Solicited local and systemic AEs within 30 minutes and 7 days after product administration/application; Secondary endpoints: Safety: • Unsolicited AEs within 28 days after product administration/application; • SAEs throughout 3 months after product administration/application; • Abnormal laboratory value analysis on Day 14 after product administration/application; Efficacy: • No growth on culture of wound base swab at 1 week after product administration/ application. * Rate of healing \> 15 % in 1 week or \>50% in 1 month Phase III: Primary endpoints: Safety: * Solicited local and systemic AEs within 30 minutes and 7 days after product administration/application; Secondary endpoints: Safety: * Unsolicited AEs within 28 days after product administration/application; * SAEs throughout 6 months after product administration/application; * Abnormal laboratory value analysis on Day 14 after product administration/application; Efficacy: * No growth on culture of wound base swab at 1 week after product administration/ application. * Rate of healing \> 15 % in 1 week or \>50% in 1 month. Phase IIB of this trial is completed and screening of Phase III is started on 31-Mar-2026.