An observational study of the correlation between stem/progenitor cell levels and wound healing in diabetic foot ulcers.

Not Applicable

• Conditions: Diabetic Foot Ulcers; Skin - Other skin conditions; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000442404
• Lead Sponsor: ational Institutes of Health (NIH),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome variable will be wound healing/closure. This will be assessed visually as either healed or not healed at 16 weeks, or earlier if healed before this point.[Wound review will occur from initial assessment on a weekly basis and measurements recorded of wound area. Final assessment of healed or not will occur at 16 weeks.]