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Skin Ulcer clinical trials

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NCT ID: NCT02798055 Completed - Scleroderma Clinical Trials

Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis

GRegistry SCDU
Start date: September 30, 2016
Phase:
Study type: Observational [Patient Registry]

GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers. The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country. The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.

NCT ID: NCT02742844 Terminated - Clinical trials for Skin Ulcer Venous Stasis Chronic

Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.

NCT ID: NCT02696460 Completed - Chronic Leg Ulcer Clinical Trials

Efficacy of 50% Nitrous Oxide/50% Oxygen Gas Premix in Chronic Leg Ulcer Debridement

Start date: April 2010
Phase: N/A
Study type: Interventional

Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.

NCT ID: NCT02685722 Completed - Clinical trials for Difficult to Healing of Skin Ulcers

UC-MSCs Gel Treatment Difficult Healing of Skin Ulcers

UC-MSCs
Start date: January 2012
Phase: Phase 1
Study type: Interventional

This study for a six-month trials, Randomized, open, and parallel comparison before and after its own, Stage test includes screening stage, treatment period and follow-up period. In accordance with chronic wound criteria for the patient, By producing the principle of random number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according to the situation of wound healing time and decided to use the secondary treatment, To observe the clinical efficacy and safety.

NCT ID: NCT02652169 Recruiting - Chronic Skin Ulcer Clinical Trials

PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4

PRF-TAT
Start date: June 2014
Phase: N/A
Study type: Interventional

Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven therapeutic efficacy. This randomised controlled trial aims to provide evidence of the efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial compounds. The investigators therefore designed a four armed trial with three PRF arms which are compared to each other as well as to an active comparator. The treatment arms are as follows: Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4: Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be included in this trial. Infection shall be diagnosed by an experienced senior infectious diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are patients with an uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a diabetic foot syndrome. Any underlying illness will be treated following standard of care. In case of chronic venous insufficiency four-layered compression bandages will be applied each visit if tolerated by the patient. Alternatively compression stockings (Class III) are permitted. This is mentioned as "Disease specific treatment" in the protocol. Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious diseases specialist.

NCT ID: NCT02619734 Enrolling by invitation - Sickle Cell Disease Clinical Trials

Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.

NCT ID: NCT02535481 Completed - Wounds and Injuries Clinical Trials

Epidermal Grafting in Wound Healing

EPIGRAAFT
Start date: October 2015
Phase: N/A
Study type: Interventional

Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. It is not known if EG is an effective alternative to SSG. Further the mechanism to achieve wound healing may be different. EG promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. Whereas SSG is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering. The investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. Further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.

NCT ID: NCT02512159 Completed - Foot Ulcer Clinical Trials

Skin Ulcers Treatment With an Handicraft Topical Device

Start date: March 2014
Phase: Phase 4
Study type: Interventional

The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

NCT ID: NCT02361437 Withdrawn - Diabetic Ulcers Clinical Trials

Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers

Start date: February 2015
Phase: N/A
Study type: Interventional

This study is designed to evaluate if Vasculera, a marketed medical food product, will improve the rate and extent of healing of diabetic ulcers.

NCT ID: NCT02309684 Not yet recruiting - Skin Ulcer Clinical Trials

Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study

Start date: January 2015
Phase: N/A
Study type: Observational

The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.