None listed
Conditions
Brief summary
The goal of this study is to evaluate whether number and intracellular protein content of stem/progenitor cells (SPCs) in diabetic patients with lower extremity neuropathic wounds (diabetic foot ulcer or DFU) are correlated with wound healing and with diabetes-related factors. The hypothesis is that SPCs-specific variables can be used to predict diabetic wound healing. This study was designed based on results from a recent preliminary clinical trial
Interventions
The goal of this study is to evaluate whether stem/progenitor cells (SPCs) in diabetic patients with lower extremity neuropathic wounds (diabetic foot ulcer or DFU) are correlated with wound healing and with diabetes-related factors. This study will take place over 8 -10 weeks.
This study will monitor the patient’s own CD34 endothelial progenitor cells (stem cells) being mobilized in response to trauma (debridement) and hyperbaric oxygen treatments.
Blood will be collected on a weekly basis fo
The goal of this study is to evaluate whether stem/progenitor cells (SPCs) in diabetic patients with lower extremity neuropathic wounds (diabetic foot ulcer or DFU) are correlated with wound healing and with diabetes-related factors. This study will take place over 8 -10 weeks. This study will monitor the patient’s own CD34 endothelial progenitor cells (stem cells) being mobilized in response to trauma (debridement) and hyperbaric oxygen treatments. Blood will be collected on a weekly basis for 8 weeks, in conjunction with debridement. It is arbitrary whether the blood is taken before or after the debridement. If indicated hyperbaric oxygen treatments will be provided on a daily basis. Debridement and hyperbaric oxygen treatments will be provided as per standard care where indicated. Only blood collection and optional punch biopsy for the thigh at entry and week 4 are considered interventions for the purpose of this research.
Sponsors
National Institutes of Health (NIH),
Eligibility
Sex/Gender
All
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Individuals who are 21 to 90, type 1 or type 2 diabetic patients with a neuropathic DFU Wagner grade 1 to 4 will be the study population. If a patient has more than one lower extremity ulcer, the one that would take the longest to heal in the opinion of the patient’s primary physician will be the target ulcer for study. To differentiate the neuropathic ulcer population from those patients with inadequate arterial blood flow (neuroischemic ulcers) all patients considered for the investigation will have skin perfusion pressure > 25 mmHg OR an ankle/brachial index of > 0.65 (if calcified vessels are suspected use the toe/brachial index). There is no predetermined wound care requirement prior to enrolment, and wound care as per best care will be provided in return for participation in the trial
Exclusion criteria
You are under the age of 21 years old or over 90 years You do not have diabetes You do not have a neuropathic foot ulcer related to diabetes You have a history of a seizure disorder You are pregnant You have: Severe asthma COPD (Chronic Obstructive Pulmonary Disease) Spontaneous pneumothorax (ruptured lung)
Outcome results
None listed