RevitalizeMe
Hyperbaric Oxygen & Wound Care
3200 Cabaret Trail S., Suite 3 | Saginaw, MI 48603
(989) 320-4434 | HyperbaricWoundCare.com
(989) 320-4434 | HyperbaricWoundCare.com
Clinical Evidence Summary
Diabetic Foot Ulcers & HBOT
FDA & CMS Approved
| Medicare & Medicaid Covered
85%
Limb salvage rate in HBOT-treated DFU patients
Faglia et al., Diabetes Care 1996
52%
Greater healing rate vs. standard care alone
Löndahl et al., Diabetes Care 2010
30+
Days of failed standard care required before HBOT coverage
CMS Coverage Policy
$40K
Average cost of a major amputation vs. HBOT course
AHRQ Cost Analysis
Clinical Overview
Diabetic foot ulcers affect 15–25% of all diabetic patients and are the leading cause of non-traumatic lower extremity amputation in the United States. Tissue hypoxia — driven by peripheral vascular disease and microvascular dysfunction — is the central pathophysiologic barrier to healing. HBOT addresses this directly by delivering supraphysiologic oxygen tensions to ischemic wound tissue, restoring the oxygen gradient necessary for healing.
Key Published Evidence
Diabetes Care — Randomized Controlled Trial
Löndahl et al. conducted a double-blind RCT in which patients with Wagner Grade II–IV DFUs received 40 sessions of HBOT or sham treatment. At one year, 52% of HBOT-treated patients achieved complete healing vs. 29% in the control group.
Löndahl M, et al. Diabetes Care. 2010;33(5):998–1003.
Diabetes Care — Prospective Controlled Study
Faglia et al. demonstrated that adjunctive HBOT significantly reduced major amputation rates in ischemic diabetic foot — 8.6% in the HBOT group vs. 33.3% in controls — a fourfold reduction in limb loss.
Faglia E, et al. Diabetes Care. 1996;19(12):1338–1343.
Medicare Coverage — NCD 20.29
CMS covers HBOT for Wagner Grade III or higher DFUs with adequate perfusion that have failed to respond to at least 30 days of standard wound care. Coverage includes Medicare, Medicaid, and most major private payors.
CMS National Coverage Determination 20.29
How HBOT Works
1
Delivers 10–13x normal oxygen to hypoxic wound tissue, restoring the healing oxygen gradient
2
Stimulates angiogenesis and new capillary formation in ischemic tissue margins
3
Enhances neutrophil bactericidal activity — critical in infected diabetic wounds
4
Reduces post-ischemic reperfusion injury and tissue edema
Ideal Referral Candidate
Wagner Grade III+ DFU with 30+ days of failed standard wound care
Adequate arterial perfusion (ABI ≥0.5 or TcPO₂ ≥30 mmHg)
Diabetic patient at risk for major amputation
Post-surgical wound breakdown with ischemic component
Standard HBOT Protocol
Pressure
2.0–2.4 ATA
Duration
90 min/session
Sessions
30–40 dives
Setting
Outpatient