View clinical trials related to Wounds.
Filter by:This prospective, placebo-controlled, double blind, randomized study is designed to assess the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies including arterial ulcers, diabetic ulcers and venous ulcers, of at least 3 months duration. After collection of comprehensive medical data to confirm eligibility of patient and obtaining informed consent , patients will enter Screening run-in Period where all wounds will be cleaned if necessary by surgical debridement and irrigation (isotonic solution) prior to initiation (run-in phase) of the study according to physician's instructions. During the 14 day screening period, all subjects will receive standard of care (SoC) on a daily basis, as per indication and patients status, according to physicians instructions. Wounds will be morphologically assessed by the treating physician and by photographic evaluation by the PI once a week - at days 7 and 14 of the screening run-in phase. Following the run-in period, Subjects with wounds of ≥ 5cm2 and ≤100 cm2 of at least 3 months duration that fail to respond to treatment with SoC during the screening run-in phase will be enrolled into the study. Eligible subjects with wounds will be randomized and treated topically with AR/101+ SoC or placebo +SoC once daily for up to 14 days. During this treatment phase I, depending on their wound size and wound type, subjects will receive treatment dose applied topically daily and wounds will be dressed according to physician's instructions. Wounds will be photographed daily and assessed by the treating physician in the clinic once a week (at the end of each weekly period). During the treatment period, adverse events and concomitant medications will be monitored; wounds will be morphologically assessed by photo documentation and followed for wound bed progression and granulation tissue formation. At the end of Treatment period I, patient's wounds will be analyzed and all patients from both treatment arms with wound score 0-2 will be assigned to receive the study drug for and additional up to 14 days treatment phase II in full accordance with the treatment regimen described in Treatment phase I. A termination visit will be performed at day 14 of Treatment phase I or II or earlier if the wound has reached the maximum score on the granulation scale or if the wound is ready for skin grafting; or in any case of early withdrawal that is not due to withdrawal of consent.
Chronic non-healing wounds represent a major source of morbidity, disability, and mortality in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations worldwide. Many patients with ischemic or neuroischemic wounds are not candidate to surgical/endovascular revascularization, owing to anatomical vascular reasons or for the underlying conditions and co-morbidities. Therefore, identification of novel medical treatment strategies to improve wound healing in diabetic patients is a major challenge for clinicians, researchers, and health care systems. Defects in bone marrow (BM)-derive stem and progenitor cells, including EPCs (endothelial progenitor cells), contribute to diabetic complications. Stem cell mobilizing agents have been previously studied as an adjunctive therapy for critical limb ischemia and chronic non-healing wounds in diabetic and non-diabetic patients, as well as for the treatment of diabetic wound infections . Meta-analyses of such studies indicate that stem cell mobilization in these clinical conditions is safe and potentially effective in improving surrogate outcome measures and hard endpoints (such as rates of wound healing and amputation). This study plans to evaluate whether a single injection of Plerixafor improves wound healing in diabetic patients with stage III-IV (neuro)ischemic wounds.
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (punch biopsy method).
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.
The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.
This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.
Chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the Canadian health care system. Microbes colonizing a chronic wound play an important role in impeding effective healing. Chronic wounds are colonized by polymicrobial communities and no single organism can be seen as causal. Only a small fraction of wound bacteria are cultured by diagnostic tests and studies have shown little agreement between culture and molecular based approaches, therefore an effective diagnostic for wound microbes is required. It is know that the composition of the microbial community associated with a wound changes as it heals although the causal relationship is somewhat unclear. Although not very effective in treating chronic non-healing wounds, antibiotics are often administered, contributing to concerns of antibiotic resistance. The wound dressings produced by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in reducing biofilm formation in vitro. However, it is not known how these silver salts impact microbial ecology of the wound and the role this plays in wound healing. The objectives of this research are to develop a new diagnostic tool based on molecular characterization of wound sites so as to predict how to best treat wounds and to identify new microbes to be targeted by ETI's technology. This project will utilize molecular microbial ecology for the assessment and evaluation of topical silver interventions, gaining insight into the management of chronic infection. Substantiating the microbiota-modifying effectiveness of silver wound dressings towards increasing clinician and patient understanding to improving clinical outcomes.
The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to 640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in human skin.
Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.