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Foot Ulcer clinical trials

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NCT ID: NCT02866565 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous Adipose-derived REGEnerative Cells in the Local Treatment of Neuropathic Diabetic Foot ulcERs

REGENDER
Start date: June 2023
Phase: Phase 2
Study type: Interventional

Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors, healing rates of DFU remain low. Mechanisms of faulty wound healing in diabetic patients are complex, related to both intrinsic and extrinsic factors. The main reasons for impaired healing appears to be: 1/exhaustion of local cell populations that promote wound healing; 2/excessive production of matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor cells and impairment of their functioning. These imbalances may result in excessive degradation of extracellular matrix components, as well as an inappropriate local inflammatory response . Adipose-derived stroma vascular fraction provides a rich and easily accessible source of autologous cells for regenerative medicine applications. Il contains multipotent stem cells and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound healing. There are attracted to the wound site where they supplement the wound bed with similar cell types, secrete numerous growth factors and cytokines, increase macrophage recruitment, enhance granulation tissue, and improve vascularisation . The reparative capabilities coupled with good safety of ADRCs have been illustrated in a study for treating severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly in patients with diffuse scleroderma. Numerous case reports showing healing of refractory wounds following treatment with autologous ADRCs have also been reported. Based on these previous reports, the present study aims to assess the efficacy and tolerance of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.

NCT ID: NCT02845466 Not yet recruiting - Clinical trials for Foot Ulcer, Diabetic

Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Start date: August 2018
Phase: Phase 3
Study type: Interventional

Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.

NCT ID: NCT02691234 Not yet recruiting - Clinical trials for Diabetic Foot Ulcers

Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers

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

Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis. The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.

NCT ID: NCT02664740 Not yet recruiting - Diabetic Foot Clinical Trials

Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus

PhagoPied
Start date: June 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.

NCT ID: NCT02413086 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Effectiveness and Safety of Early-Stage Amputation and External Herbs Chitosan for Diabetic Foot Ulcer

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

Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors leading to limb amputation, it was reported that the amputation rate is 15 times of the non-diabetic patients. Common surgical amputation is not only about high plane amputation but also bring a tremendous mental stress to patients which may affect the quality of life seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia , and septic shock which could be the main cause of death before amputation. It become an important topic that how to control the infection, reduce the amputation plane, save the function as possibility, and improve the life quality of the patients as well. This study is based on years of clinical experience of and brings out "early-stage amputation" concept firstly in China with a systematic exposition, experimental research and clinical research. Early-stage amputation refers to cut in the normal tissue from the inflammatory tissue at the junction line of limbs, in order to achieve more retained stump, block endotoxin absorption and improve the quality of life of patients. External therapy of herbs chitosan can promote granulation tissue regeneration and control of local infection, it solved the problem of difficult wound healing and it is a reliable guarantee of early-stage amputation.

NCT ID: NCT02209662 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers

Start date: October 2014
Phase: N/A
Study type: Interventional

Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be randomized into one of two groups, the Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce growth factors that can help in wound healing.

NCT ID: NCT01418456 Not yet recruiting - Diabetes Clinical Trials

Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics

KADFUT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form. - All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group. - The antibiotic group will receive standard treatment along with antibiotics. - The control group will have standard treatment alone. - Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks. - Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes

NCT ID: NCT00776854 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Bioburden Reduction of Diabetic Foot Ulcer

Start date: November 2008
Phase: Phase 1
Study type: Interventional

Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer