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Executive Summary Table 1Strength of Evidence - Advanced Wound Care Therapies for Diabetic Ulcers

TreatmentControl(s)OutcomeNumber of Studies (n for Primary Outcome)*CommentsStrength of Evidence
CollagenStandard carePercentage of ulcers healed4 (483)One study reported significant improvement compared to standard care. Three studies reported no significant difference between collagen and standard care. Trials were rated as fair quality.Low
Mean time to ulcer healingOne trial found a significant difference favoring standard care; two found no difference.Low
Biological DressingsAdvanced therapy control (PDGF, BSE)Percentage of ulcers healed2 (99)Two fair quality trials showed no difference compared to other advanced wound care therapies.Low
Mean time to ulcer healingNo trial was significantly different versus control.Low
Biological Skin Equivalents [BSE] – DermagraftStandard carePercentage of ulcers healed3 (505)A trend toward statistically significant improvement compared to standard care (RR=1.49, 95% CI 0.96 to 2.32, I2=43%). Trials were rated as fair quality.Low
Mean time to ulcer healingInconsistent results, with one trial reporting a significant difference versus standard care. Trials were rated as fair quality.Low
BSE – ApligrafStandard carePercentage of ulcers healed2 (279)Two trials of fair quality found statistically significant improvement versus standard care (RR=1.58, 95% CI 1.20 to 2.08, I2=0%).Moderate
Mean time to ulcer healingOne trial reported a significant difference between Apligraf and standard care.Low
BSE – ApligrafAdvanced therapy control (Skin allografts - Theraskin)Percentage of ulcers healed1 (29 ulcers)One fair quality trial found no significant difference versus Theraskin.Low
Mean time to ulcer healingNo significant difference versus Theraskin.Low
Platelet Derived Wound Healing [PDGF]Placebo /standard carePercentage of ulcers healed7 (685)Overall statistically significant improvement versus placebo (RR 1.45 [95% CI 1.03 to 2.05]) but results were inconsistent (I2 85%). Overall study quality was rated as fair.Low
Mean time to ulcer healing5 (731)Overall, PDGF demonstrated shorter duration of time to ulcer healing versus placebo.Low
PDGFAdvanced therapy control (BSE, silver, sodium carboxymethylcellulose)Percentage of ulcers healed3 (189)No significant differences compared to an advanced therapy comparator. Trials were rated as fair quality.Low
Mean time to ulcer healingNo significant differences compared to an advanced therapy comparator.Low
Platelet-Rich Plasma [PRP]Placebo gel, Platelet-Poor PlasmaPercentage of ulcers healed2 (96)Neither of the studies (fair to poor quality) demonstrated a significant difference between PRP and its respective control.Low
Mean time to ulcer healingSignificantly shorter healing time compared to platelet-poor plasma. No significant difference versus placebo gel.Low
Silver ProductsStandard care or advanced therapy controls (calcium-based dressing, oak bark extract, polyherbal creamPercentage of ulcers healed4 (280)One trial found silver ointment more effective than standard care. Two trials found no difference in healing between a silver cream or dressing and another advanced care product. Studies were of fair quality.Low
Mean time to ulcer healing2 (174)Two trials found no difference between silver and another advanced wound care product.Low
Negative Pressure Wound Therapy [NPWT]Standard care (Advanced moist wound therapy, saline gauze)Percentage of ulcers healed1 (335)One trial of good quality found 43% in the NPWT group experienced ulcer healing compared to 29% treated with standard care (RR=1.49, 95% CI 1.11 to 2.01).Moderate
Mean time to ulcer healing3 (432)Results for time to healing were inconsistent based on 3 trials of mixed quality.Low
Hyperbaric Oxygen Therapy (HBOT)Sham or standard carePercentage of ulcers healed4 (233)Three long-term studies of fair quality found significant improvement with adjunctive HBOT versus sham or standard care; one short-term study found no difference.Low
Mean time to ulcer healing-Outcome not reported.Insufficient
HBOTAdvanced therapy control (Extracorporeal shockwave therapy)Percentage of ulcers healed1 (84)One trial of poor quality found adjunctive HBOT less effective than extracorporeal shockwave therapy.Low
Mean time to ulcer healing-Outcome not reported.Insufficient
Ozone-Oxygen TherapyShamPercentage of ulcers healed1 (61)One trial of fair quality found no significant difference between ozone-oxygen and sham.Low
Mean time to ulcer healing-Outcome not reported.Insufficient
*

Number of ulcers evaluated for the primary outcome

The evidence is rated using the following grades: (1) high strength indicates further research is very unlikely to change the confidence in the estimate of effect, meaning that the evidence reflects the true effect; (2) moderate strength denotes further research may change our confidence in the estimate of effect and may change the estimate; (3) low strength indicates further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate, meaning there is low confidence that the evidence reflects the true effect; and (4) insufficient, indicating that the evidence is unavailable or does not permit a conclusion.

Number of ulcers evaluated for the primary outcome

From: EXECUTIVE SUMMARY

Cover of Advanced Wound Care Therapies for Non-Healing Diabetic, Venous, and Arterial Ulcers: A Systematic Review
Advanced Wound Care Therapies for Non-Healing Diabetic, Venous, and Arterial Ulcers: A Systematic Review [Internet].
Greer N, Foman N, Dorrian J, et al.
Washington (DC): Department of Veterans Affairs; 2012 Nov.

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