Affinity Prospective Diabetic Foot Trial Crossover Group
Diabetic Foot UlcerThis study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.
Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment
Diabetic Foot UlcerThe purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the healing of foot ulceration in diabetic patients.
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
DiabetesThe investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
Shockwave Therapy of Chronic Diabetic Foot Ulcers
Diabetic Foot UlcerIntroduction: Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations. Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown. Purpose: The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers. Hypothesis: The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects. Method: Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview. Significance: ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers....
Diabetic Foot UlcerThis is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
Treatment of Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient...
Diabetic Foot UlcerHammer Toe2 moreAim Patients with diabetes, hammer, mallet and claw toes and ulcers associated with the named deformities will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. The effects of the surgery on time to healing of ulcers associated with the named deformities, recurrence of the ulcers, and rate of complications associated with the surgery. In addition to this all patients gait and balance will be examined before start of the study, and after 3 months, to se if there is an effect of the surgery on patients gait and balance. Method A prospective randomized clinical study, which means a study were patients will be allocated randomly to surgery and standard care or standard care alone. Patients will attend a total of up to 14 visits over a 12-month period. 3.
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal...
Diabetic Foot UlcerThe aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
Omnigen DFU Pilot Study
Diabetic Foot UlcersThe Omnigen Pilot study aims to provide an evidence base for Omnigen as a treatment for Diabetic Foot Ulcers (DFU). It aims to achieve this by tailoring a regenerative therapy used for ocular surface repair to provide proactive non-surgical wound management of Diabetic Foot Ulcers (DFU).
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing...
Diabetic Foot UlcerPressure Ulcer4 moreThe study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Wound Healing DisorderEffect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer